With a highly qualified team, Pharma & Biotech Consulting offers comprehensive expertise and experience in key regulatory functions. Our team members are authorized to act as Qualified Person according to §14 AMG and Annex 16 of the EU-GMP Guide ("Qualified Person") as well as Responsible Person according to §52a AMG ("Responsible Person").

We are also available as external Head of Manufacturing and Quality Control according to §12 AMWHV.

With our extensive expertise and certification, we are capable of ensuring the highest standards of quality and safety. Our services cater to companies seeking experienced professionals to implement regulatory requirements efficiently and professionally. Pharma & Biotech Consulting ensures that all relevant legal requirements are met so you can focus on your core competencies. Rely on us as a trusted partner for challenging tasks in the pharmaceutical and biotech industry.

• Qualified Person according to §14 AMG and Annex 16 EU-GMP Guide ("Qualified Person")
  
  
• Responsible Person according to §52a AMG ("Responsible Person")
  
  
• Head of Manufacturing / Quality Control according to §12 AMWHV