Challenges of Advanced Therapy Medicinal Products (ATMPs)
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Confidence Beyond Compliance
With increasing globalisation of Pharmaceutical supply chains, the supply chain now often extends across multiple transportation routes and regulatory jurisdictions, presenting specific challenges to the organisation in terms of preserving the quality and integrity of the pharmaceutical product across the supply chain.
Current regulatory requirements and expectation is that the pharmaceutical organisation has full awareness, control and management of the supply chain from sourcing API and excipients through manufacture of the pharmaceutical product and transportation to the customer, and implements the appropriate QA systems and procedures for assuring quality and compliance and for preventing falsified medicines from entering the supply chain.
PharmaLex’s team of experts, which includes a number of former EU regulators, provide expert Quality and Compliance support services to your organisation from both high-level QA strategic planning and decision making through to the provision of a Virtual QA service across your pharmaceutical product supply chain.
- Working with your Quality, Operations, Supply Chain and Regulatory teams to map the supply chain, including the quality and regulatory compliance roles and responsibilities of your organisation and of your contractors, vendors and third parties involved in the supply chain
- Developing the Pharmaceutical Management System framework required to manage quality across the supply chain, as per ICH Q10, including the wider responsibilities of the Marketing Authorisation Holder (MAH) such as pharmacovigilance, medical information, promotion and advertising
- Documenting QA procedures (SOPs), elements of the QMS framework, describing quality procedures impacting on the supply chain, and also QA procedures for preventing falsified medicines from entering the supply chain
- Providing contract Virtual QA services by:
- acting as your company’s Quality Operations contract service provider in Europe
- assessing and qualifying your contractors, vendors and third parties through auditing, using the principles for Risk Management as per ICH Q9
- periodic reassessment of your contractors and vendors as per your vendor management programme
- preparing your Quality/Technical Agreements with your contractors, vendors and third parties, to include assigning roles and responsibilities for Quality Assurance to both parties
- monitoring QA metrics reported for your contractors, vendors and third parties and presenting to your Quality and Supply Chain functions
- managing your self inspection programme
- acting as your Responsible Person (RP) for quality defects and product recalls, supporting your responsibilities as Marketing Authorisation Holder
- providing contract Qualified Person (QP) services on your Manufacturer/Importation Authorisation (MIA)
- providing Qualified Persons for Pharmacovigilance (QPPV) services
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We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.
Med Device company, US
Senior Regulatory Affairs Director
Senior Regulatory Affairs Director
Hard working and there when you need them
Europe based large biotech
Regulatory Manager
Regulatory Manager
