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 requested
Review Marketing Authorisation variations
Perform training with impacted personnel on SOPs
Perform quality and regulatory activities as required by internal SOPs
Liaise with HPRA & EMA
Review and approval of annual Product Quality Review
Review and approval of Annual Product Quality
Perform external audits and participate in internal audits when applicable
Apotech’s consultant has been quickly onboarded and managed to get some results very promptly. She knew well how to use the investigation tools, and she managed to understand our SOPs and our QMS easily. Her focus on becoming familiar with our process and product has been key in her achievement. It has been a very seamless support!
Key numbers
Team
0,4 FTE
Location
Remote
Length
18 months
Type
Time and Material
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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small. Get in touch