Medicines

Qualified Person (DE/AT) / Responsible Person (CH)

We take over the function of QP/RP for your company on a permanent or ad-interim basis.

• Batch Certification (Batch Release)
• Head of Quality Control § 14 AMG i. V. m. § 12 AMWHV (DE) 
• Graduated Plan Officer § 63a AMG (DE)
• Information Officer § 74a AMG (DE)
  
• Narcotic Drugs Officer acc. BtMG (DE) 
  
• Responsible Person for Promotion according to art. 25 TPAO (CH)

Establishment and Maintanance of Quality Management Systems (QMS) 

We advise and support you in setting up, maintaining and optimizing your QMS in accordance with GDP and GMP guidelines in Germany, Austria and Switzerland.  

• Compilation of Standard Operating Procedures (SOPs)
• Preparation of Health Authority Inspections 
• Conduction of Self Inspections
• Conduction of External Audits (API, FP)
• Support with complex root cause analyses in the context of deviations
• Product Quality Review (Preparation, Review, Oversight)
• GMP Training and Capacity Building

Development and validation of new analytical methods

We develop independent solutions in the field of analytical methods in the customer's laboratory.

• HPLC and Dissolution
• Method transfers with project management for all transfer activities

Medical Devices

Market access for Medical Devices in Switzerland

We advise and support you in the appointment of the Swiss Authorized Representative (CH-REP) and the implementation of your obligations as a Swiss importer and distributor of Medical Devices.

• Registration CH-REP and CH-Importer to obtain the CHRN
• Compliant labeling of the products

Post-Market Surveillance and Vigilance 

We take over the function of Person Responsible for Regulatory Compliance (PRRC) for your company.