Archemin

Advice & reporting for the chemical and pharmaceutical industries

Quality Systems for the Pharmaceutical, Biotech, Diagnostics and Medical Device Industries

In the light of the ever increasing complexity of the regulatory environment, companies must rely on efficient and transparent quality systems. Every company functions in a different way and therefore, there is no off-the-shelf-fits-all solution. A quality system should be as simple as possible to ensure optimal acceptance and compliance.

The Archemin team

  • provides advice, guidance and assistance in the development of Standard Operating Procedures
  • develops and manages the implementation of CAPA plans
  • prepares companies for and supports them during inspections
  • performs audits, reviews or compiles contracts between various partners involved in the implementation of the quality system
  • edits training manuals, provides and documents trainings

Good Distribution Practice

  • Application for a wholesale and distribution license (local as well as international trade) for Medicinal Products (including narcotics, cold chain), Medical Devices, Active Pharmaceutical Ingredients
  • Development and maintenance of the procedure handbook
  • Training of warehouse personnel
  • Preparation of and support during Audits by the National Health Authorities or Customers
  • Warehouse and Transport Validation
  • Temperature Mapping

Pharmacovigilance, Materiovigilance, Cosmetovigilance

  • Development and maintenance of the procedure handbook
  • Training
  • Preparation of and support during Audits by the National Health Authorities

ISO 13485

  • Gap analysis
  • Development and maintenance of quality systems compliant with the most recent internationally recognised industrial standard ISO 13485:2003 for the medical device industry
  • Setup of a document management system and programmation of the required software
  • Validation of the process management system
  • Training
  • Preparation of and support during Audits by the Certification Bodies

Want to know more / require a quote ?

Send your request to qa-qc [at] archemin [dot] eu