Commercial Pharmaceuticals

We have developed a proven track record of assisting clients in accessing the UK, USA, and EU markets, collaborating with various businesses ranging from multinational pharmaceutical companies to small Marketing Authorization Holders (MAHs), helping them establish the relevant licences in market and operate them efficiently, effectively and also ensuring compliance. We specialise in making the QMS fit for purpose and supportive of the business. 

  We have supported clients in setting up Wholesale Distribution Authorizations (WDAs) and Marketing Authorization Applications (MAAs), establishing compliant supply chains.

We provide Responsible Person and Responsible Person for Import (RPi) services, and contract Qualified Person (QP) services. As well as a range of specialist QA services.

Book a 30 min consultation to discuss your needs.

Our services include:

Technical Project Management

We offer review and project management for significant process deviations (e.g. aseptic media fill failure, batch and validation failures) and change management support (from new lines, new process and technical transfer). Helping our clients resolve the challenges quickly effectively and pragmatically. Our expertise extends to project planning and providing technical and quality support for commissioning, qualification, and validation projects, is extensive. including electronic QMS implementation.

Book a 30 min consultation to discuss your needs.

Responsible Person (RP) Services

The Responsible Person role is a UK/EU and exists in many similar forms across the world who follow EU Pharmaceutical regulations 2003/94/EC. The role is set out in European commission's Good Distribution Practice (GDP) Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and has been adopted across the world. 

This guidance stipulates the requirement of the Responsible Person (RP) as well as their duties and obligations expected of them by undertaking this role. The RP must have extensive experience and a high level of knowledge to meet the regulatory authorities' expectation. They must have demonstrated competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines.  

We help our clients by providing Skilled Professionals who can act as RPs and RP (import) (RPi) servicing and provide various levels of service to meet our clients' needs and reequipments:  

  • Supporting clients to obtain their wholesaler dealer authorisations (WDAs) 

  • Building Quality Systems in compliance with GDP  

  • Acting as an external support network for an internal RP 

  • Acting on an ongoing basis as a contract RP 

  • Training for new wholesalers e.g. topic or GDP update training 

  • Remediation of Adverse regulatory findings

  • Supply chain management and structuring / restructuring

  • Independent Supply chain due diligence and auditing

Our strength is to develop a project plan specifically tailored to the client and their business needs, allowing us to collaborate together to achieve the end goals. With broad experience of computerised system implementation development and validations.

Book a 30 min consultation to discuss your needs.

License Acquisition & QMS setup

We have a proven history of establishing pharmaceutical licenses in the UK and EU for our clients and helping them to maintain them compliance the complex pharmaceutical regulations across the UK and EU.

We work with our extensive network of highly experienced QPs and RPs to help build out MIAs for all Pharmaceutical products and supply chain strategies.  

Additionally, we assist in obtaining other common global, UK, EU, and USA pharmaceutical licenses, including Good Manufacturing Practice (GMP) licenses helping our clients fully discharge their Marketing Authorization Holder (MAH) responsibilities.

We and our partners can help with all of your USA Food and Drug Administration (FDA) quality and regulatory filings. Including writing and reviewing Master files (Type II: Drug substance, drug substance intermediates, and material used in their preparation, or drug product, Type III: Packaging material, etc). We also support Investigational New Drug (IND) Application, New Drug Application (NDA), Biologics License Applications (BLA), Abbreviated New Drug Application (ANDA), and pre-approval inspection (PAI) for your site and drug project. Providing review, technical writing and PAI preparation and simulation services.

Book a 30 min consultation to discuss your needs.

Remediation

Adverse Inspection out comes are increasingly common as estates and facilities age and the regulation continues to develop and become increasingly stringent and robust.  

Combining over 70 years of quality leadership and experience we help our clients manage and resolve FDA 483 notices and Consent Decree remediations from the FDA as well as competent authority inspection observation remediations from across the world: 

  • USA (FDA) 

  • UK (MHRA), 

  • EU (AIFA, ANSM , IGJ, BASG, EMA, AEMPS, BDA, NAMMDR) and  

  • Around the world (TGA, ANVISA, Health Canada, Swissmedic, PMDA, Medsafe, MFDS, SFDA, SAHPRA, TMMDA etc)

 Our remediation services assess and improve quality systems to ensure they meet regulatory requirements and industry best practices from across the world. 

We work wholistically, comprehensively and pragmatically to resolve the issue and add value.

Book a 30 min consultation to discuss your needs.

Inspection Readiness 

GMDP and GCP regulations and guidelines are complex being ready for an inspection is often a daunting and challenging task. The medical and pharmaceutical regulations have ever-increasing expectations of licensees. As medicines evolve to ever more complex products. Unfortunately, around 10% of Inspections end in significant non-compliance findings we have extensive experience in managing non-compliance events.

We work to prevent these events helping our clients prepare for regulatory inspections and avoid these events using a combination of audit, process evaluation and Subject Matter Expert "coaching" and development of "storyboards" to prepare SMEs for complex presentations and discussions with Regulators.

  • Investigations 

  • Inspection preparation and gap assessments 

  • Simulations of Inspections 

  • Gap closure and remediation 

  • On the day Front and Back-room services 

By drawing on the skills and knowledge of our staff and associates, to ensure you can expertly and expediently respond before, during and after the inspection and manage the inspection process to achieve a positive outcome.

Book a 30 min consultation to discuss your needs.

Auditing Services and Vendor Management

We navigate the complex landscape of regulatory compliance with confidence. Our experienced accredited auditors using the ISO 19011 process for audit management.  

Total Delivery Pharma conduct thorough assessments and audits by remote and onsite audits to confirm compliance and to identify areas for improvement and ensure adherence to industry standards covering the following Audit Standards.  

Partner with Total Delivery Pharma Services for a future where quality is not just a standard – it's a commitment. For more details click here.

Further we can support you in managing your supply chain support the development and optimisation of your risk management process for outsourced supply chain. Our team has years of experience managing complex global pharmaceutical supply chains and vendors. Offer expert support and intervention and risk management services. Help deal with challenging issues and situations, from due diligence to tech transfer and very thing in between.

Book a 30 min consultation to discuss your needs.

Validation and Qualification Services

Our team of seasoned experts possesses deep industry knowledge and extensive experience in navigating the intricate web of regulatory guidelines. Whether you're a small-scale operation or a large pharmaceutical enterprise, we offer tailored solutions to meet your unique validation and qualification needs. 

Our comprehensive suite of services includes: 

  • Validation Strategy Development: Crafting a customized validation strategy aligned with your business objectives and regulatory requirements

  • Equipment Qualification: Ensuring that all equipment used in the manufacturing process meets regulatory standards through thorough qualification procedures 

  • Process Validation: Validating manufacturing processes to guarantee consistency, reliability, and compliance throughout production

  • Analytical Method Validation: Validating analytical methods to ensure accurate and reliable testing of pharmaceutical products

  • Cleaning Validation: Verifying the effectiveness of cleaning procedures to prevent cross-contamination and ensure product safety

  • Computer System Validation: Validating computer systems to ensure data integrity, security, and compliance with regulatory requirements

  • Documentation Support: Assisting with the preparation and maintenance of validation documentation, including protocols, reports, and standard operating procedures (SOPs)

  • Witness and process sign off: We can attend your site at key steps and confirm the suitability and completeness of testing and qualification as independent third party experts

No matter your needs, no matter the stage in the project we are here to help. 

Book a 30 min consultation to discuss your needs.

QA Person in Plant & Person on the Floor

In the fast-paced environment of pharmaceutical manufacturing, having a dedicated Quality Assurance (QA) presence both in the plant and on the floor is essential for maintaining the highest standards of quality and compliance. At Total Delivery Pharma we recognize the critical role that QA personnel play in ensuring the integrity of pharmaceutical processes and products. 

QA Person in Plant services: 

Our QA Person in Plant service entails placing experienced quality assurance professionals directly within your manufacturing facility or that of your CMO. These seasoned experts serve as your eyes and ears on the production floor, proactively monitoring operations, conducting inspections, and ensuring adherence to standard operating procedures (SOPs) and regulatory guidelines. Managing cases and incidents as they happen and providing an intendent expert analysis in the moment. By embedding QA personnel within your plant, we provide real-time oversight and support to identify and address quality issues swiftly, minimizing the risk of non-compliance and product deviations. 

Person on the Floor: 

Our Person on the Floor service goes beyond traditional QA inspections by placing dedicated personnel directly on the production floor for the duration of the production activities. These individuals work closely with manufacturing teams, fostering a culture of quality and compliance at every stage of the production process. Whether it's conducting in-process inspections, verifying critical control points, or providing on-the-spot training and guidance, our Person on the Floor ensures that quality is built into every batch of pharmaceutical products from inception to completion. 

Benefits of Our Services: 

  • Enhanced Quality Control: Our QA personnel provide continuous monitoring and oversight to maintain the highest standards of quality throughout the manufacturing process

  • Immediate Issue Resolution: With dedicated personnel on-site, potential quality issues can be identified and addressed promptly, minimizing the risk of product deviations and non-compliance

  • Regulatory Compliance: Our services help pharmaceutical companies uphold compliance with regulatory requirements, mitigating the risk of regulatory actions and product recalls

  • Improved Efficiency: By proactively addressing quality concerns and streamlining processes, our services contribute to increased operational efficiency and productivity

Partner with Us: 

At Total Delivery Pharma services we understand the importance of having a strong QA presence in pharmaceutical manufacturing. Our QA Person in Plant and Person on the Floor services are tailored to meet the unique needs of your operation, providing you with the assurance and support necessary to deliver safe, high-quality pharmaceutical products to market.

Book a 30 min consultation to discuss your needs.

QA Batch Review Services

Welcome to Total Delivery Pharma, your trusted partner in ensuring the quality and compliance of pharmaceutical products through our comprehensive QA & QP Batch Review services. Our dedicated team is committed to upholding the highest standards of safety, efficacy, and regulatory compliance in every batch we review. 

QA Batch Review: 

At Total Delivery Pharma, our QA Batch Review service is designed to meticulously examine each production batch, verifying adherence to regulatory standards, SOPs, and product specifications. Our experienced QA professionals conduct thorough assessments of documentation, including batch records and analytical data, to guarantee accuracy and consistency throughout the manufacturing process. With our rigorous review process, we help mitigate the risk of product deviations and non-compliance, ensuring the integrity of your pharmaceutical products. 

Benefits of Partnering with Total Delivery Pharma: 

  • Compliance Assurance: Our QA Batch Review services ensure compliance with regulatory requirements, reducing the risk of non-compliance and regulatory actions

  • Enhanced Product Quality: By conducting thorough batch reviews, we enhance the safety, efficacy, and reliability of your pharmaceutical products, fostering trust among stakeholders

  • Risk Mitigation: Our rigorous review processes help mitigate the risk of product deviations, recalls, and adverse events, protecting your company's reputation and bottom line

  • Expert Guidance: With our team of experienced professionals, including QPs and QA specialists, you can rely on expert guidance and support throughout the batch review process

Partner with Total Delivery Pharma: 

Total Delivery Pharma is dedicated to delivering excellence in QA & QP Batch Review services. We collaborate closely with pharmaceutical companies to provide tailored solutions that meet their specific needs and regulatory requirements. With our comprehensive expertise and attention to detail, you can trust us to deliver reliable, compliant, and high-quality batch reviews for your pharmaceutical products.

Book a 30 min consultation to discuss your needs.

Ensuring MHRA Compliance with Confidence (We Are part of the MHRA Compliance Monitor Scheme) 

Is your company facing MHRA compliance challenges? 

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a vital role in ensuring the safety and quality of medicines in the UK. Following an inspection, if your company is identified as needing improvement in adhering to Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), the MHRA may refer you to the Inspection Action Group (IAG). 

Adam Slater can act as a compliance monitor under the scheme. For further information, please refer to the MHRA website. 

Together Adam and the team will review and ensure compliance with agreed-upon Compliance Protocol (CP). Supervise the implementation and execution of the process. He and the team will help you Deliver on your remediation plan.

Book a Compliance Monitor Discovery and Consultation Call Today:

 

 AFFILIATIONS

CLIENT FEEDBACK

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP