Regulatory affairs

Regulatory Affairs department is the corner stone of Pharmassist, consisting in a very large Team with over 18 years of experience. Pharmassist's Regulatory Affairs Team a lengthy experience in providing full/ad hoc regulatory support to multinational companies and SME.

Registration and Life-cycle management of marketing authorisations

  • Collection of technical data and scientific writing of chemical and pharmaceutical documentation
  • Preparation of registration dossiers in CTD, NeeS and eCTD format for National, MR and DC Procedures
  • Provision of accurate translations of scientific documents (SPCs, PILs, training material)

Non-pharma products

  • Biocides
  • Cosmetics
  • Medical Devices
  • In-vitro diagnostics
  • Food Supplements

Compliance

  • Supervision and management of promotional activities

Pricing & Market Access

  • Provision of advice and handling of Pricing and Reimbursement issues