The requirements of regulatory authorities are complex, ever changing and hardly ever worded in absolute terms. By assuring compliance with the most recent Guidelines and Directives, PharmaVize provides you with quality regulatory solutions and advice on the best regulatory strategy. Our key services in regulatory affairs include:

Dossier preparation

• Literature search
• Evaluation of technical data
• Statistical analysis
  Regulatory strategy & intelligence
• Gap analysis and expert review
• Control-of-Change (CoC) regulatory assessment 

Technical writing

• Marketing authorisation dossiers according to Notice to Applicants and Common Technical Document (CTD) standards
• Application dossiers for a Certificate of Suitability (CEP) or Active Substance Master File (ASMF)
• Product labelling (SmPC, PIL,…)
• Readibility testing
• Pricing and reimbursement dossiers
• TSE dossiers
• Notification dossiers 

Dossier submission

• Paper and electronic publishing
• Administration and logistics of your application
• Electronic submissions
• Planning and handling of agency meetings (including preparation of briefing documents)
• Liaison with Benelux and other EU authorities (EMEA, EDQM) at all stages of the procedure
• Preparing answers to deficiency letters

Dossier maintenance

• CTD conversions
• Preparation of variations and renewals

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