Medicinal Products

Medicinal Products : Small Molecules and Biologics

Service overview

Real Regulatory is able to meet all your EU regulatory needs for small molecules and biologics.

Medicinal Product consulting services

  • Clinical development strategy
  • Licensing and product life cycle strategy
  • Handling multi-national Clinical Trial Applications (CTAs)
  • Substantial amendment, end of trial notification, study report submissions
  • Preparation and management of scientific advice applications and Paediatric
  • Investigation Plans (PIPs)
  • Orphan Drug Designation
  • Preparation and management of Marketing Authorisation Applications (MAAs)
  • Applicant and sponsor enterprise services for EU
  • Sourcing of experts for overviews and briefing documents
  • Due diligence technical review and consulting
  • Process mapping of regulatory activities
  • Tracking and monitoring of regulatory submissions
  • Active Substance Master File (ASMF) or Drug Master File (DMF) submissions
  • Variation, renewal and urgent safety restriction submissions
  • Supply status reclassifications
  • Periodic Safety Update Reports (PSURs)

Typical projects

Project: Grouped Type II variation submission for an oncology product
Client: A small pharmaceutical company
Challenges: A grouped variation was submitted to the European Medicines Agency (EMA) with tight timelines for approval due to drug supply issues
Our Solution: Real Regulatory reviewed the data to be submitted and decided the best strategy for submission to include all changes. They also ensured that the manufacturer was briefed and kept up to date with their responsibilities and timelines with regular meetings. Weaknesses or gaps in the submitted data were identified in advance and responses were prepared so questions could be responded to promptly.

Project: Submission of a hybrid application of a well-established endocrinologic drug
Client: A mid-sized pharmaceutical company
Challenges:  Submission of a new national MAA application was made to the French Agency (ANSM) as an article 10(3) hybrid application.
Our Solution: Real Regulatory supported the client by informing them on the exact requirements of French Agency. This included requirements on the content of the dossier, on the format and the requirement to submit in eCTD format. For the purpose of the Application, Real Regulatory was the Marketing Authorisation Holder. The dossier was built in conjunction with the client. Real Regulatory have a French speaker in house who was the first point of contact with the Agency and managed all communication between the Agency and the client. Questions received from the Agency were translated in a timely manner to action the response in conjunction with the client and meet the deadline.

See our Frequently Asked Questions (FAQs)

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