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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.

Types of Audits

  • cGMP
  • ISO 9001
  • GDPR
  • Trackwise, World Excel, power point
Frame 1000005946

Scope of work

Done

Remote batch certification and release of medicinal products

Done

Provide regulatory expertise as requested

Done

Review Marketing Authorisation variations

Done

Perform training with impacted personnel on SOPs

Done

Perform quality and regulatory activities as required by internal SOPs

Done

Liaise with HPRA & EMA

Done

Review and approval of annual Product Quality Review

Done

Review and approval of Annual Product Quality

Done

Perform external audits and participate in internal audits when applicable

Have a project in mind_ Let’s work together!
Client quote

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

Management

Team

0,4 FTE

Charity

Location

Remote

Combo Chart

Length

18 months

WeChat

Type

Time and Material

Excited to work together on your next project?

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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.