Quality Services

We offer support in the following areas:

Quality Systems

• Evaluation and optimization of existing Quality Management Systems.
• Implementation of a Quality Management system from scratch

Quality Evaluations, Improvements

• Gap Analysis, Audits / on-site Assessments
• Knowledge of all national and international guidelines and requirements
• Experience in the preparation, coordination and follow-up of international inspections from Regulatory Authorities
• Excellent knowledge in the areas of biotech, FDF and API manufacturing, development
• Risk Management, eg Annual Product Reviews, Complaint Trending, ICH-Q3D
• Impact assessments, eg during change control

Supplier Audits, Due Diligence Audits

• Experienced and international Team 
• Excellent knowledge in the areas of biotech, FDF and API manufacturing, development
• Audit CAPA Tracking

Batch Release and Batch Certification

• We take full responsibilities for batch release /Qualified person (14 AMG) service after notifying the respective Regulatory Authorities
• Batch Certification and release with QP declaration
• Batch release of clinical studies
• Batch release for special products, eg biologics
• Batch release testing and certification
• Import Release for finished products for companies located outside the EU /EWR

Wholesale Responsible Person according AMG §52a

• Act as Wholesale Responsible Person
• Implementation of GDP Systems

MAH, Marketing Authorisation Holder 

Interesting offer for manufacturers or companies, which:

• need a compliant QA Management system according to Good Manufacturing Practices (GMP) or a compliant Pharmacovigilance System
• are manufacturers outside the European Union (eg Suisse, US, China, India, etc) and intend to launch products within the European Union (EU / EWR) 

Training

Execution of Trainings and Workshops in the area of:

• Quality Systems
• GMP initial training and refreshers
• Pharmaceutical law
• Good Distribution Practice