Consulting
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Strategic and regulatory advice for national / international Issues
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Strategy formation for new development concepts, partly
in cooperation with RCPE -
Choice of appropriate application procedures
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Evaluation of regulatory or CMC documentation
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Compilation of a complete MA dossier
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Regulatory and commercial compliance
- Life Cycle Management (Variations, Renewal procedures,...)
- Product Quality Reviews -
Quality management
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Preparation and attendance at meetings with authorities
(pre-submission meetings, scientific advice) -
Support in the area of CE-Certification
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Health claims
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Pharmacovigilance assistance
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Non-Clinical & Clinical Studies
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Application for SME status
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Application for Scientific Advice related to Quality, Non-Clinic or Clinic