Acta Pharma Services can handle all the mainstream activities associated with marketing authorisations and clinical trial applications. Our services include:
Submission services
- Development of regulatory strategies for Europe
- Planning and management of National, Decentralised and Centralised Procedures
- Regulatory authority liaison, hearings and appeals
- Planning and handling of agency meetings (including preparation of briefing documents)
- Interpretation of regulatory guidelines and advice on strategy
Documentation services
- Preparation and maintenance of regulatory dossiers for APIs (DMFs and Certificates of Conformity) and finished products (Marketing Applications)
- Preparation of Quality Overall Summaries for Dug Substance and Drug Product
- Preparation and auditing of Manufacturers’ Licences
- Maintenance of marketing approvals including preparation of applications for licence variations
- Conversion of dossiers to CTD format
- Scientific report writing
- Preparation of product labelling and artwork
Project management
- Critical review of scientific and technical data against regulatory requirements
- Due diligence for licensing projects
- Preparation and filing of responses to regulatory questions
- Follow up with customer's internal departments and with company's external partners
- Short-term replacement of staff and project support
- Training in Regulatory Affairs
