Generic Medicinal Products

Real Generics is able to meet all your EU regulatory needs for generic pharmaceuticals. Here is a sample of the services that we offer:

  • Licensing and product lifecycle strategy
  • Preparation and management of Marketing Authorisation Applications (MAAs)
  • Active Substance Master File (ASMF) or Drug Master File (DMF) submissions
  • Variation and renewal submissions
  • Sourcing of experts for overviews
  • Due diligence technical review and consulting
  • Process mapping of normative regulatory activities
  • Tracking and monitoring of regulatory submissions
  • Commercialisation activities
  • Regulatory compliance activities

Application Types

  • Essentially similar or generic
  • Informed consent
  • Bibliographic
  • Hybrid
  • Parallel Import

Submission Types

  • Marketing Authorisation Application (MAA)
  • Parallel Import Application
  • Active Substance Master File (ASMF) or Drug Master File (DMF)
  • Certificate of Suitability
  • Variation, renewal and urgent safety restriction
  • Supply status reclassification
  • Periodic Safety Update Report (PSUR)

Typical Projects

Project: Regulatory intelligence – Identification of regulatory hurdles for submission of a non-standard generic in a European country.

Client: Medium-sized pharmaceutical company.

Challenges: The client wished to submit a non-standard generic of an essential product in a European country, but was concerned by the total absence of generic competition in the target market, considering that generic competition for the same product was tough in other European markets. Our assistance was sought in identifying possible regulatory hurdles.

Our Solution: By drawing on our experience and thoroughly examining the regulatory history of the molecule throughout Europe, we were able to identify four possible reasons for the absence of generics on the market, enabling the client to be better informed and to fully assess risk-benefit before submission.

Project: Complete regulatory support.

Client: A small pharmaceutical company.

Challenges: The client has no in-house regulatory experts and relies on Real Generics for all regulatory activities.

Our Solution: This is an ongoing, long-term project. Real Generics facilitates the client’s activities by acting as an off-site regulatory affairs department, working closely with the client’s own staff. Services provided include: dossier due diligence for in-licensing purposes, background research, formulation of regulatory strategy, marketing authorisation application preparation, submission management.

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