Our Services

    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