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General services within Regulatory affairs
A-pharmaconsult provides professional regulatory affairs assistance to companies in the phases of development, production, registration, and marketing of pharmaceutical products.
- Regulatory writing:
- All Modules of the Marketing Authorisation application, including
Literature search and documentation review,
Expert statements,
Summaries/Overviews
- Switch core dossiers
- Drug product information
- Maintenance of Marketing Authorisations:
- Compliance review and Deficiency report writing for dossier update
- Conversion of NTA dossier into CTD format
- Management of variation, line extension and renewal dossier
- Regulatory submission:
- Management of dossiers under National, Mutual Recognition or Decentralised Procedures
- Clinical Trial Applications
- Regulatory consulting:
- Drug regulatory requirements
- Registration strategy
- Ad hoc regulatory intelligence
This list is not exhaustive, we provide assistance in many other areas. Please do not hesitate to contact us, with your particular requirements or to get further information.
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