New Activities

Since 2003 Labline has intensively extended its service for

• Regulatory affairs

• Qualified person (Q.P.) service

• Audit

• Pharmacovigilance system and QPPV

• Self-inspection

• SOPs, PQRs, PSURs according to EU-GMP and AMWHV

 
Experience (30 years) in

• Registration and marketing authorization of drugs and medical devices

• Analytical, clinical and pharmaco-toxicological dossiers in CTD-format

• Expertise of clinical, pharmaco-toxicological and analytical dossiers

• Clinical report for medical devices

• Packaging information leaflets (PIL), labels, and folded box

• Drug residues and safety

• Ecotoxocological reports and risk assessment

• Conversion of NTA to CTD-Dossiers

• Drug manufacturing

• Drug analysis

• Issuing more than 1000 reports for Germany and other countries on different drugs

  in German and English language

Associations with

• University institutes for pharmaceutical technology in Germany and India

• Different multinational to small pharmaceutical companies

  in Germany and India

• Different professors and medical personal

Consultancy or direct participation in    

• Marketing authorisation

• Preparation of CTD-format dossiers (Module 1-5)

• Manufacturing contact

• Manufacturing and analysis of drugs as per EU-GMP and AMWHV

• Bioequivalent studies

• Animal tests

• Development of food supplements