Case Studies
At Apotech, we have worked with a
huge range of clients all around the world.
With consultants and teams present in 30 key life science markets, we have successfully executed projects in over 110 countries and helped a large number of innovative medical devices and products enter the market with complete regulatory compliance.
Keep reading to discover some of our most recent case studies.
GCP Audits – Europe
Seagen is a global biotechnology company dedicated to revolutionizing cancer care. They are Headquartered in the US & Switzerland with a large footprint in the EU.
Outsourced internal GMP & GVP Audits
Outsourced internal GMP & GVP Audits Introduction Multinational biotech The French affiliate of a multinational Biotech company has its own QMS. Upon the QP responsibility, they conduct their internal audit with a 3-year plan (at the end of a 3 year cycle, they have audited all of their processes). Apotech consultants 2 External auditors Both…
GVP Audits Worldwide
GVP Audits Worldwide Introduction US Biotechnology Our client is a global Biotechnology company dedicated to genetics and molecular biology. They are Headquartered in the US, with offices in most major economies. Apotech auditors Our Auditors have 20+ years’ experience in the industry and have all conducted over 100 GVP audits. Types of Audits Affiliate Distributor/…
GMP Audits
GMP Audits Introduction UK Based Biotech The company is a worldwide large biotech with a vast portfolio of biotech products (mainly oncology). Apotech auditors: 3 auditors are involved in this partnership. Types of Audits Contracts/agreements between the clients and the provider GMP/GDP Client SOPs Local regulations Audit Locations Europe The audited sites are: Client manufacturing…
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
GxP Audits – Worldwide
GxP Audits – Worldwide Introduction Global Biopharmaceutical Our client is a global biotechnology company dedicated to novel treatments for patients through inhibition of protein kinases to fight cancer. They are Headquartered in the US, with a large footprint in the EU. Types of Audits GCP – For Cause / Investigator / Phase 1 unit GCLP – Central…
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as…
Tech Transfer
Tech Transfer (COVID-19 Vaccine) Introduction Worldwide Vaccine Manufacturer British-Swedish multinational pharmaceutical and biotechnology company. Areas Oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. Apotech Consultants The Apotech Consultants were embedded in the client’s global TechOps team. This team consisted of ~50 people, spread across the globe, and our consultants reported to the Director of Global…
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…