Quality Assurance and Quality Management

 

Pharma & Biotech Consulting provides comprehensive support to companies in quality assurance and quality management. Our goal is to assist you in establishing, updating, and transforming effective quality systems – essential for obtaining and maintaining the necessary licenses and certifications that ensure smooth business operations. We not only prepare all required documentation but also implement the associated processes, utilizing proven methods and standards. Upon request, we can also handle operational tasks to make the transition to an optimized quality management system as seamless as possible.

 

Our expertise extends far beyond the basic requirements. In the context of corporate acquisitions, mergers, or investments, we offer technical due diligence, providing a comprehensive analysis and evaluation of existing quality systems. This enables investors and companies to make informed decisions and identify potential risks early on.

 

Our range of services includes support in obtaining key permits, such as manufacturing authorization (§13 AMG), wholesale authorization (§52 AMG), narcotics license (§3 BtMG), and import certificates (§72 AMG). We also assist in applying for GMP, GDP, GLP, and GVP certifications, create and maintain relevant master plans and policies, and conduct comprehensive risk analyses. Additionally, we provide all necessary qualification and validation documents and handle the validation of computerized systems (CSV).

 

Furthermore, we manage Quality Technical Agreements, as well as creation and updating of standard operating procedures (SOPs) and product quality reviews (PQRs). With our support, you can ensure that your quality systems consistently meet the highest regulatory standards and are optimally tailored to the specific needs of your company.

Services:

 

  • Obtaining manufacturing authorization (§13 AMG), wholesale authorization (§52 AMG), narcotics license (§3 BtMG), import certificate (§72 AMG)
  • Obtaining certifications (GMP, GDP, GLP, GVP)
  • Master plans and policies
  • Risk analyses
  • Qualification and validation documents
  • Validation of computerized systems (CSV)
  • Quality Technical Agreements
  • SOP and PQR