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
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
Key numbers
Team
0,4 FTE
Location
Remote
Length
18 months
Type
Time and Material
Excited to work together on your next project?
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and welln...
Find out more
Global in-country regulatory support
510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range f...
Find out more
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innova...
Find out more
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was lo...
Find out more
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharma...
Find out more
EU-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the ...
Find out more
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regula...
Find out more
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive card...
Find out more
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with h...
Find out more
Prosthesis manufacturer
Prosthesis manufacturer Introduction Global API Manufacturer As part of their international development strategy, our client wanted to get MDSAP certified with ...
Find out more