Consulting

• Strategic and regulatory advice for national / international Issues

•  Strategy formation for new development concepts, partly
      in cooperation with RCPE

• Choice of appropriate application procedures

• Evaluation of regulatory or CMC documentation

• Compilation of a complete MA dossier

• Regulatory and commercial compliance   
      - Life Cycle Management (Variations, Renewal procedures,...)
      - Product Quality Reviews

• Quality management

• Preparation and attendance at meetings with authorities
    (pre-submission meetings, scientific advice)

• Support in the area of CE-Certification

• Health claims

• Pharmacovigilance assistance

• Non-Clinical & Clinical Studies

• Application for SME status

• Application for Scientific Advice related to Quality, Non-Clinic or Clinic