Investigational Pharmaceutical
Sponsor QMS Design, Maintenance, and Implementation Services
Total Delivery Pharma (TDP), is your dedicated partner in designing, maintaining, and implementing Quality Management Systems (QMS) for Investigational Pharmaceuticals. Our comprehensive services are meticulously crafted to assist sponsors in achieving compliance with regulatory requirements, including the guidelines outlined in the European Medicines Agency's (EMA) Reflection Papers, U.S. Food and Drug Administration (FDA) Guidelines and that of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Designing a Robust QMS:
At Total Delivery Pharma, we recognize the critical role of a well-designed QMS in ensuring the quality and integrity of Investigational Pharmaceuticals. Our seasoned team collaborates closely with sponsors to develop customized QMS frameworks that align with regulatory expectations and best practices outlined in the EMA guidelines. From defining quality objectives to establishing risk-based approaches, we create QMS solutions tailored to your specific needs and objectives.
Maintenance and Continuous Improvement:
Our commitment to excellence extends beyond QMS design—we also offer comprehensive maintenance services to ensure ongoing compliance and effectiveness. Through regular assessments, audits, and reviews, we help sponsors identify areas for improvement and implement corrective and preventive actions (CAPAs) to address any deficiencies. By fostering a culture of continuous improvement, we ensure that your QMS remains robust, adaptable, and responsive to evolving regulatory requirements and industry standards.
Implementation Support:
Implementing a QMS can be a complex and challenging process. At Total Delivery Pharma, we provide hands-on support and guidance to sponsors throughout the implementation phase. From staff training to documentation management, we help streamline the transition to a new QMS, minimizing disruptions to your operations and maximizing the efficiency and effectiveness of your quality processes.
Benefits of Partnering with Total Delivery Pharma:
Regulatory Compliance: Our QMS solutions are designed to meet the stringent requirements outlined in the EMA guidelines, ensuring compliance with regulatory expectations and industry standards
Quality Assurance: By implementing robust QMS frameworks, we help sponsors maintain the quality and integrity of Investigational Pharmaceuticals, safeguarding patient safety and data integrity
Operational Efficiency: Our tailored QMS solutions streamline processes, reduce redundancies, and optimize resource allocation, enhancing the efficiency and productivity of your organization
Risk Mitigation: Through proactive risk management and continuous improvement initiatives, we help sponsors mitigate the risk of non-compliance, product recalls, and regulatory actions
Partner with Total Delivery Pharma:
At Total Delivery Pharma, we are dedicated to supporting sponsors in the design, maintenance, and implementation of QMS solutions for Investigational Pharmaceuticals. With our expertise, experience, and commitment to quality, we empower sponsors to navigate the complexities of regulatory compliance with confidence and ease.
Contact us today to learn more about how our QMS design, maintenance, and implementation services can support your organization and ensure the success of your Investigational Pharmaceutical programs.
Book a 30 min consultation to discuss your needs.
Clinical Trial Phase Transitioning Support Services
We understand the critical importance of seamless transitions between clinical trial phases to ensure the success and efficiency of drug development programs.
Navigating Phase Transitions with Confidence:
Moving from one phase of a clinical trial to another requires meticulous planning, coordination, and execution. Crossing the GMP and GCP landscapes not to mention GVP and CMC MS&T challenges. With over 70 years of expertise Total Delivery Pharma, we offer comprehensive support services to guide you through each phase transition with confidence. Whether you're transitioning from preclinical to Phase I, Phase II to Phase III, Phase III in to early stage commercialisation and launch planning our experienced team is here to help streamline the process and maximize the likelihood of success.
Our Phase Transition Support Services Include:
Strategic Planning: We work closely with your team to develop a strategic plan tailored to your specific clinical trial program. Our experts help you anticipate challenges, set clear objectives, and establish timelines to ensure a smooth transition between phases
Regulatory Compliance: Our team stays up-to-date with the latest regulatory requirements and guidelines to ensure compliance throughout the transition process. We assist with regulatory submissions, approvals, and documentation to keep your clinical trials on track
Protocol Development: We provide support in refining and optimizing study protocols to align with the objectives of each phase of your clinical trial. Our goal is to enhance the efficiency and effectiveness of your research while maintaining patient safety and data integrity
Data Management: Effective data management is crucial during phase transitions. We offer comprehensive data management services, including data collection, analysis, and reporting, to ensure that you have the insights you need to make informed decisions at every stage of your clinical trial
Quality Assurance: Our QA experts conduct thorough reviews and audits to ensure that all aspects of your clinical trial, from study design to data collection, meet the highest quality standards. We help identify and address any issues or discrepancies to maintain the integrity of your research
Commercialisation and Launch Planning: In addition to navigating the clinical trial phases, we also provide expertise in commercialization and launch planning. Our team assists you in developing strategies to successfully bring your pharmaceutical product to market, manage supply chain transitions and evaluating market analysis, pricing strategies, distribution planning. Estimation of consumption and reserve stock needs
We take an integrated GxP risk management approach and help you find success.
Why Choose Total Delivery Pharma?
Expertise: Our team brings extensive experience and expertise in clinical trial management, regulatory affairs, and quality assurance to ensure successful phase transitions
Customized Solutions: We understand that every clinical trial is unique. That's why we offer tailored solutions designed to meet the specific needs and objectives of your research program
Commitment to Excellence: Total Delivery Pharma is committed to excellence in everything we do. We prioritize quality, compliance, and customer satisfaction to deliver exceptional results for our clients
Partner with Us:
When it comes to Clinical Trial Phase Transitioning Support Services, Total Delivery Pharma is your trusted partner every step of the way. Contact us today to learn more about how our services can support the success of your clinical trial programs.
Book a 30 min consultation to discuss your needs.
Ethics and IRAS
Ethics and Institutional Review Board (IRB) Services
We understand the critical importance of ethical considerations in pharmaceutical research and development. Our dedicated team is committed to ensuring that your clinical trials adhere to the highest ethical standards and regulatory requirements. With experience with preparing submitting and reviewing Institutional Review Board (IRB) and Ethical review committees (ERC) we will provide you with expert support in making applications to and responding to regulatory Ethical review committees.
Ethics Consultation:
Our Ethics Consultation services provide expert guidance and support to navigate the complex ethical considerations inherent in clinical research. Whether you need assistance with protocol development, participant recruitment process, informed consent procedures, or ethical dilemmas that arise during the course of your study, our team is here to help. We work closely with sponsors, investigators, and research teams to address ethical concerns and promote the well-being of study participants. Our team actively sit on Ethics Panels and are experience in both submission and review of clinical trial research applications.
Institutional Review Board (IRB) Support:
Navigating the IRB/IEC review process can be challenging. Total Delivery Pharma offers comprehensive support services to facilitate the submission and approval of your research protocols. Our team assists with preparing IRB/IEC submissions, addressing reviewer comments, and ensuring compliance with ethical guidelines and regulatory requirements. With our expertise, you can navigate the IRB/IEC review process with confidence and efficiency.
Ethics Training and Education:
We believe in the importance of fostering a culture of ethics and integrity within pharmaceutical research organizations. Total Delivery Pharma offers customized training and education programs to equip research teams with the knowledge and skills necessary to conduct ethical clinical trials. Our training modules cover topics such as ethical principles, regulatory requirements, informed consent, and best practices in human subjects protection.
Why Choose Total Delivery Pharma for Ethics and IRB Services?
Expertise: Our team of ethics experts and regulatory professionals brings extensive experience in navigating ethical considerations and IRB/IEC review processes
Compliance: We ensure that your clinical trials adhere to all relevant ethical guidelines and regulatory requirements, mitigating the risk of non-compliance and regulatory actions
Commitment to Participant Welfare: Total Delivery Pharma is dedicated to protecting the rights, safety, and well-being of study participants throughout the clinical trial process
Tailored Solutions: We understand that each research study is unique. Our services are customized to meet the specific needs and objectives of your study, ensuring a personalized approach to ethics and IRB support
Partner with Total Delivery Pharma:
When it comes to Ethics and Institutional Review Board (IRB) services, Total Delivery Pharma is your trusted partner for ethical, compliant, and successful clinical trials. Contact us today to learn more about how our services can support the ethical conduct of your research studies.
Book a 30 min consultation to discuss your needs.
IMP Supply Chain Management
We understand the critical importance of an efficient and reliable supply chain in the successful conduct of clinical trials. Our dedicated team is committed to ensuring seamless IMP distribution, storage, and management throughout the lifecycle of your clinical trial.
Assessment of Manufacturers:
Total Delivery Pharma conducts thorough assessments of IMP manufacturers to ensure they meet the highest standards of quality and compliance. We evaluate manufacturing facilities, processes, and quality control measures to guarantee the integrity and reliability of the products supplied for your clinical trials.
Assessment of Distributors:
Our team also assesses distributors to ensure they adhere to strict quality and compliance standards. We evaluate distribution facilities, storage conditions, and handling procedures to ensure the safe and secure transportation of IMPs from manufacturer to study sites.
Preparation of Supply Chains:
Total Delivery Pharma prepares supply chains tailored to the specific requirements of your clinical trial, including ambient, cold chain, ultra-low temperature frozen goods, and cryo shipments. We ensure that each supply chain is optimized for efficiency, reliability, and regulatory compliance.
Shipping Validations and Qualifications:
We conduct shipping validations and qualifications to verify the suitability and effectiveness of shipping methods and containers. Our team performs rigorous testing to ensure that IMPs are transported safely and maintain their integrity and stability throughout the shipping process.
Shipping Lane Risk Minimization and Optimization:
Total Delivery Pharma minimizes risks associated with shipping lanes through careful planning and optimization. We assess potential hazards, such as temperature variations, customs regulations, and transit times, to identify and mitigate risks proactively. Our goal is to optimize shipping routes for efficiency, reliability, and cost-effectiveness while minimizing the potential for disruptions or delays.
Why Choose Total Delivery Pharma for IMP Supply Chain Management?
Expertise: Our team brings extensive experience in pharmaceutical supply chain management, ensuring the success of your clinical trials
Global Reach: We have the capabilities to manage IMP distribution to study sites worldwide, ensuring access to investigational products wherever your trials take place
Reliability: Total Delivery Pharma is committed to reliability and on-time delivery, providing peace of mind throughout the duration of your clinical trial
Compliance: We adhere to all relevant regulations and guidelines governing the handling, storage, and distribution of IMPs, helping to ensure compliance and patient safety
Partner with Total Delivery Pharma:
When it comes to IMP Supply Chain Management, Total Delivery Pharma is your trusted partner for efficiency, reliability, and compliance. Contact us today to learn more about how our services can support the success of your clinical trials.
Book a 30 min consultation to discuss your needs.
Clinical Trial Inspection Readiness
We are your dedicated partner for Clinical Trial Inspection Readiness. We understand the importance of being prepared for regulatory inspections to ensure compliance and maintain the integrity of your clinical trials. Our experienced team is here to support you every step of the way, from preparation and training to on-site assistance during inspections.
Comprehensive Inspection Preparation:
Total Delivery Pharma offers comprehensive inspection preparation services to help you navigate the complexities of regulatory inspections with confidence. We conduct thorough assessments of your clinical trial operations, documentation, and processes to identify areas for improvement and ensure readiness for inspections.
Training and Education:
Our training and education programs are designed to equip your team with the knowledge and skills necessary to prepare for and respond to regulatory inspections effectively. We offer customized training sessions covering topics such as Good Clinical Practice (GCP) guidelines, documentation management, and inspection readiness strategies.
Mock Inspections:
Mock inspections provide valuable opportunities to simulate real-life inspection scenarios and identify potential areas of concern before regulatory inspectors arrive. Total Delivery Pharma conducts mock inspections tailored to your specific clinical trial protocols and regulatory requirements, allowing you to address any deficiencies and enhance your readiness for inspections.
On-Site Assistance:
During regulatory inspections, Total Delivery Pharma provides on-site assistance to support your team and ensure a smooth and successful inspection process. Our experienced professionals are available to answer questions, provide documentation, and address any issues that may arise, helping you demonstrate compliance and maintain a positive rapport with inspectors.
Post-Inspection Support:
Following regulatory inspections, Total Delivery Pharma offers post-inspection support to help you address any findings or observations identified during the inspection. We work collaboratively with your team to develop and implement corrective and preventive actions (CAPAs) to address deficiencies and improve compliance for future inspections.
Why Choose Total Delivery Pharma for Clinical Trial Inspection Readiness?
Experience: Our team brings extensive experience in clinical trial operations and regulatory compliance, ensuring thorough preparation and effective response to inspections
Customized Solutions: We tailor our inspection readiness services to meet the specific needs and requirements of your clinical trials, providing personalized support and guidance
Compliance Focus: Total Delivery Pharma is committed to helping you achieve and maintain compliance with regulatory requirements, safeguarding the integrity of your clinical trials and protecting patient safety
Partner with Total Delivery Pharma:
When it comes to Clinical Trial Inspection Readiness, Total Delivery Pharma is your trusted partner for thorough preparation, effective training, and on-site support during regulatory inspections. Contact us today to learn more about how our services can help you achieve inspection readiness and ensure the success of your clinical trials.
Book a 30 min consultation to discuss your needs.
Trial Master File (TMF) Auditing and Compliance Assessment
Your trusted partner for Trial Master File (TMF) Auditing and Compliance Assessment. Our services are designed to ensure that your TMF is maintained in accordance with the highest standards of quality, integrity, and compliance, as outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline.
1. Organization and Management of Clinical Trials
Total Delivery Pharma conducts comprehensive audits of TMFs to assess the organization and management of clinical trials. Our team evaluates the completeness, accuracy, and timeliness of TMF documentation, ensuring that essential documents are appropriately filed, indexed, and accessible.
2. Investigator Selection and Responsibilities
We assess the selection and responsibilities of investigators as documented in the TMF to ensure compliance with regulatory requirements. Our audits verify that investigators are qualified, trained, and compliant with protocol requirements, ethical principles, and regulatory obligations.
3. Informed Consent Process
Total Delivery Pharma conducts thorough reviews of informed consent documentation within the TMF to assess compliance with regulatory requirements and ethical standards. We verify that informed consent forms are appropriately obtained, documented, and retained in accordance with protocol requirements and applicable regulations.
4. Data Quality and Integrity
Our audits evaluate the data quality and integrity within the TMF to ensure the reliability and accuracy of clinical trial data. We verify that data collection, handling, and reporting procedures are conducted in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
5. Safety Reporting
Total Delivery Pharma assesses safety reporting documentation within the TMF to ensure compliance with regulatory requirements for adverse event reporting and safety monitoring. Our audits verify that adverse events are promptly reported, documented, and appropriately managed in accordance with protocol requirements and regulatory obligations.
6. Study Monitoring
We review monitoring documentation within the TMF to assess the effectiveness of study monitoring activities. Our audits verify that monitoring visits are conducted in accordance with the monitoring plan, protocol requirements, and GCP guidelines, ensuring the integrity and reliability of clinical trial data.
Why Choose Total Delivery Pharma for TMF Auditing and Compliance Assessment?
Expertise: Our team brings extensive experience in clinical trial management, regulatory compliance, and TMF auditing
Comprehensive Approach: We conduct thorough audits to assess all aspects of TMF compliance, ensuring the integrity and reliability of clinical trial documentation
Compliance Focus: Total Delivery Pharma is committed to helping you achieve and maintain compliance with regulatory requirements, safeguarding the integrity of your clinical trials and protecting patient safety
Partner with Total Delivery Pharma:
When it comes to TMF Auditing and Compliance Assessment, Total Delivery Pharma is your trusted partner for thorough evaluation, effective remediation, and ongoing compliance support. Contact us today to learn more about how our services can help you achieve TMF compliance and ensure the success of your clinical trials.
Book a 30 min consultation to discuss your needs.
Investigator Brochure Writing, Review and Assessment
Your trusted partner for Investigator Brochure (IB) Writing, Review, and Assessment. Our comprehensive services are designed to ensure that your IBs are accurate, informative, and compliant with regulatory requirements, facilitating the successful conduct of clinical trials.
Writing Investigator Brochures:
Total Delivery Pharma offers expert writing services to create comprehensive and scientifically accurate Investigator Brochures. Our experienced medical writers collaborate closely with subject matter experts to develop IBs that provide essential information about the investigational product, including its pharmacology, pharmacokinetics, safety profile, and proposed clinical development plan.
Review and Assessment:
We conduct thorough reviews and assessments of existing Investigator Brochures to ensure accuracy, completeness, and compliance with regulatory requirements. Our team evaluates IBs against relevant guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2), to identify any gaps or deficiencies and recommend appropriate revisions.
Compliance Assessment:
Total Delivery Pharma conducts comprehensive compliance assessments of Investigator Brochures to ensure adherence to regulatory requirements and industry standards. Our team verifies that IBs contain accurate and up-to-date information, properly cite relevant literature and data sources, and comply with guidelines for content and format outlined in regulatory guidelines.
Why Choose Total Delivery Pharma for Investigator Brochure Services?
Expertise: Our team includes medical writers, regulatory experts, and clinical researchers with extensive experience in writing, reviewing, and assessing Investigator Brochures
Regulatory Compliance: We ensure that Investigator Brochures comply with relevant regulatory requirements and guidelines, minimizing the risk of deficiencies or delays in regulatory submissions
Scientific Rigor: Total Delivery Pharma is committed to maintaining scientific accuracy and integrity in Investigator Brochures, providing stakeholders with reliable and trustworthy information about investigational products
Partner with Total Delivery Pharma:
When it comes to Investigator Brochure Writing, Review, and Assessment, Total Delivery Pharma is your trusted partner for excellence in scientific communication and regulatory compliance. Contact us today to learn more about how our services can support the success of your clinical development programs.
Book a 30 min consultation to discuss your needs.
Pharmacy Handbook Writing, Review and Assessment
TDP is your trusted partner for Pharmacy Handbook (PH) Writing, Review, and Assessment. Our comprehensive services are designed to ensure that your Pharmacy Handbooks are informative, accurate, and compliant with regulatory requirements, supporting efficient pharmacy operations and pharmaceutical care delivery.
Writing Pharmacy Handbooks:
Total Delivery Pharma offers expert writing services to create customized Pharmacy Handbooks tailored to the needs of your pharmacy practice. Our experienced pharmacy writers collaborate closely with subject matter experts to develop handbooks that provide clear guidance and instructions on pharmacy procedures, protocols, and best practices.
Review and Assessment:
We conduct thorough reviews and assessments of existing Pharmacy Handbooks to ensure accuracy, relevance, and compliance with regulatory requirements. Our team evaluates handbooks against relevant guidelines, such as those outlined by regulatory bodies or professional organizations, to identify any gaps or deficiencies and recommend appropriate revisions.
Compliance Assessment:
Total Delivery Pharma conducts comprehensive compliance assessments of Pharmacy Handbooks to ensure adherence to regulatory requirements and industry standards. Our team verifies that handbooks contain accurate and up-to-date information, properly cite relevant regulations and guidelines, and comply with standards for content and format.
Why Choose Total Delivery Pharma for Pharmacy Handbook Services?
Expertise: Our team includes pharmacy writers, regulatory experts, and pharmacy practitioners with extensive experience in writing, reviewing, and assessing Pharmacy Handbooks
Regulatory Compliance: We ensure that Pharmacy Handbooks comply with relevant regulatory requirements and guidelines, minimizing the risk of deficiencies or non-compliance
Practical Guidance: Total Delivery Pharma is committed to providing practical and actionable guidance in Pharmacy Handbooks, supporting pharmacy staff in delivering safe, effective, and efficient pharmaceutical care
Partner with Total Delivery Pharma:
When it comes to Pharmacy Handbook Writing, Review, and Assessment, Total Delivery Pharma is your trusted partner for excellence in pharmacy practice support and regulatory compliance. Contact us today to learn more about how our services can enhance the effectiveness and efficiency of your pharmacy operations.
Book a 30 min consultation to discuss your needs.
Management of Investigator Site Integration and Hospital Aseptic Processing and Manufacturing of IMPs
TDP is your comprehensive solution provider for both the Management of Investigator Site Integration and Hospital Aseptic Processing and Manufacturing of Investigational Medicinal Products (IMPs). We offer tailored services to support the seamless integration of investigator sites and ensure the quality manufacturing of IMPs within hospital settings.
Investigator Site Integration and Hospital Aseptic Processing and Manufacturing of IMPs:
We help sponsor and hospital co-ordinate and develop protocols for onsite manipulations of IMPs to ready to administer pharmaceutical products streamlining operations and enhancing collaboration between sponsors, investigators, and study teams. Our services include site selection support, feasibility assessments, regulatory submission support, and ongoing support to ensure efficient site activation.
We provide hospitals and healthcare facilities with comprehensive support for aseptic processing and manufacturing of IMPs managing the discreet individual requirement restriction on site, ensuring that variation and risk are minimised and process meet GMP standards and clinical best practice.
Benefits of Partnering with Total Delivery Pharma:
Streamlined Operations: Our integrated approach to investigator site management and hospital manufacturing optimizes processes and reduces administrative burden, saving time and resources.
Quality Assurance: Total Delivery Pharma prioritizes quality assurance throughout all aspects of our services, ensuring the integrity and safety of pharmaceutical products produced and distributed.
Regulatory Compliance: We adhere to current Good Manufacturing Practice (cGMP) guidelines and regulatory requirements, providing hospitals and sponsors with confidence in the compliance and integrity of our services.
Why Choose Total Delivery Pharma:
Expertise: Our team brings extensive experience and expertise in clinical trial management, pharmaceutical manufacturing, and regulatory compliance
Customized Solutions: We offer tailored solutions to meet the unique needs and requirements of each investigator site and hospital, ensuring optimal outcomes for all stakeholders
Commitment to Excellence: Total Delivery Pharma is committed to delivering exceptional service and exceeding client expectations in every aspect of our operations
Partner with Total Delivery Pharma:
Whether you require support for investigator site integration, hospital manufacturing of IMPs, or both, Total Delivery Pharma is your trusted partner for comprehensive solutions. Contact us today to learn more about how our services can support the success of your clinical trials and pharmaceutical manufacturing endeavours.
Book a 30 min consultation to discuss your needs.
AFFILIATIONS
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