Services

Product Lifecycle Management

Real Regulatory can support or act as your European Regulatory team. Marketing Authorisations require updates to maintain compliance with the current regulations and ongoing changes to the product. These activities are applicable to all types of licencing, National, Mutual Recognition, Decentralised or Centralised procedure. With our extensive local knowledge, both in-house and external, we can cover all European markets for any regulatory lifecycle activities, including but not limited to the following:

  • Assigning or recommending the appropriate variation category
  • Regulatory strategy for the submission
  • Preparation of quality, clinical and safety expert statements if required to support the change
  • Preparation of submission package including cover letter, application form, and update Module
  • Review and update SmPC, PIL, and labelling
  • Review and update of all local package information in local language
  • Publishing of the submission in eCTD format and submission via CESP or applicable portal
  • PSUR submission
  • Regulatory review of advertisement material and submission (where applicable)
  • Annual Product Review (APR)
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