Quality Assurance and compliance for pharma, biotech, medical devices

Quality assurance services

In the highly regulated world of life sciences, quality assurance (QA) is not just a requirement – it’s a strategic asset. At Arex Advisor, we offer expert QA consultancy services tailored for pharmaceutical, biotech, and medical‑device companies operating across the EU, UK, and Switzerland.

Whether you need to implement a robust Quality Management System (QMS), secure Qualified Person (QP) or Responsible Person (RP) services, prepare for audits, or manage GMP/GDP compliance – we partner with you throughout the entire product lifecycle, from development to market and beyond.

Quality & compliance services

Good Manufacturing Practice

Good Distribution Practice

Quality compliance for Medical Devices

FAQ: Good Manufacturing Practice (GMP)

What is EU GMP?

EU GMP stands for “European Good Manufacturing Practice.” It defines the minimum quality standard that medicines (and active substances) must meet during manufacturing to ensure safety, quality and efficacy.

A quality assurance consultant can support by helping translate high‑level GMP principles into a concrete compliance plan tailored to your product type and supply‑chain setup.

Where can I find the official EU GMP requirements / EU GMP Guide?

The official requirements are compiled under EudraLex Volume 4 (the “EU GMP Guide”). For human and veterinary medicines, this is the legally binding framework. 

A quality assurance consultant can support you by mapping which parts (e.g. Part I, Part II, relevant Annexes) apply to your product – avoiding over‑ or under‑implementation of GMP standards.

Which authority enforces GMP in the EU / how to find the competent authority for a given manufacturing site?

Enforcement of GMP in the EU is coordinated by the European Medicines Agency (EMA), but inspections are carried out by the national competent authority (NCA) of the member state where the manufacturing site is located.

An expert consultant adds value by helping you identify the correct NCA if you use or plan supply from sites in different EU countries, and by supporting interactions with each relevant authority.

How can I check if a manufacturing site holds a valid GMP certificate in Europe?

For sites in EU/EEA, there typically is an official “certificate of GMP compliance” — often recorded in inspection databases. The responsible national inspectorate issues a GMP compliance certificate after inspection. 

A consultant can perform due diligence on potential CMOs or API suppliers – verifying certificate scope (e.g., manufacturing, packaging, import) and expiry and advising whether the site aligns with your intended use (e.g., clinical vs commercial supply).

Do GMP requirements apply to investigational medicinal products (IMPs) for clinical trials in the EU?

Yes – GMP applies to IMPs as well, under the general EU GMP framework (EudraLex Volume 4), when these are manufactured, imported or released for use in clinical trials.

A consultant can support you by defining a GMP‑compliance strategy for IMP manufacturing or import, preparing the required documentation (site master files, batch‑release procedures, etc.), and liaising with authorities to ensure compliance from the start.

Are there specific GMP rules for sterile or aseptically manufactured products (e.g. injectables)?

Yes – for sterile medicinal products, specific GMP standards apply (typically via relevant annexes of the EU GMP Guide), reflecting the higher risk associated with aseptic production.

A quality assurance consultant helps interpret which Annexes or standards apply (e.g. Annex 1), ensure site and process design comply, and support qualification of CMOs or internal production according to sterile‑product GMP standards.

What about importing active substances (APIs) from outside the EU - does EU GMP still apply?

 For APIs imported into the EU, manufacturers/importers must ensure compliance with EU GMP standards. The importation must follow procedures laid out under EU legislation and often requires a written confirmation or certificate that the non‑EU API manufacturer meets GMP requirements equivalent to EU GMP.

A consultant adds value by helping you manage supply‑chain compliance: assessing third‑country API suppliers, ensuring required written confirmations or equivalent GMP compliance documentation are in place, and supporting import authorisation and batch‑release readiness.

 

FAQ: Good Distribution Practice (GDP)

What is EU Good Distribution Practice (GDP)?

EU GDP is the standard that regulates distribution (storage, transport, wholesale distribution, export, etc.) of medicinal products and active substances in the EU/EEA, to ensure their quality, integrity, traceability and safety throughout the supply chain.

A quality assurance consultant can help interpret these requirements in the context of your supply chain – ensuring you set up compliant distribution, storage and transport processes from day one.

Where can I find the official EU GDP guidelines / regulatory text?

The current official guidelines are published in the document Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).

A consultant can map the guideline chapters/clauses to your operations (e.g. wholesale distribution, qualifications, logistics) – helping you understand exactly which parts apply.

Who needs to comply with GDP - which actors in the supply chain?

Compliance is required for wholesale distributors, warehouses, parallel distributors, and any entity holding a wholesale‑distribution authorisation in the EEA.

A quality assurance expert adds value by helping you identify all relevant supply‑chain actors (CMOs, logistics, wholesalers, importers) and making sure contractual and regulatory responsibilities are clear.

What are the core requirements under EU GDP (e.g. storage, transport, documentation)?

The GDP guidelines cover – among others – quality management systems, qualified premises and equipment, personnel training and roles (incl. “Responsible Person”), correct documentation and traceability, proper transport and temperature‑control for sensitive products, procedures for handling returns, recalls, complaints, and preventing falsification, and requirements for outsourced activities (e.g. transport providers or brokers).

A consultant can help you design and implement a compliant quality system for distribution – including SOPs, transport agreements, risk‑based audits, and documentation – adapted to your product type and supply chain.

How can I check whether a distributor/importer is GDP compliant (e.g. has a valid authorisation)?

In the EU/EEA, companies performing wholesale distribution must hold a wholesale distribution authorisation issued by the relevant national competent authority. Their authorisations (and any GDP certificates or non‑compliance statements) should be recorded in the publicly accessible EudraGMDP database.

A quality assurance consultant can perform due diligence: check EudraGMDP, verify authorisation scope (wholesale, import, APIs, etc.), and assess if the distributor/importer is suitable for your supply chain needs.

Does GDP also cover active pharmaceutical ingredients (APIs), not only finished medicines?

Yes – for active substances intended for manufacture of medicinal products in the EEA, importers and distributors must register and comply with GDP requirements.

A consultant can help ensure that your API supply chain – potentially involving third‑country manufacturers, importers, and EU distributors – is GDP‑compliant, including documentation, registration, and batch‑traceability.

What happens in transport - who is responsible, and what are the GDP obligations for carriers/transport providers?

Under EU GDP, the supplying wholesale distributor (or the entity responsible according to agreement) must ensure that transport of medicinal products complies with GDP – including appropriate temperature control, protection against damage, adulteration or theft, documented traceability, and use of qualified carriers (if outsourced).

A quality assurance expert can support by reviewing and drafting contracts with carriers, qualifying transportation providers, defining temperature‑controlled transport requirements, and ensuring traceability and compliance along the transport legs of the supply chain.

Your contact person
Portrait of Delphine Guérin

Delphine Guérin

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.