Abbriged applications for generics and hybrids

Find a path through the regulatory landscape

When the data exclusivity period for a medicinal product is coming to an end it opens the possibility for other companies to register their own products, partly based on the data of the original product. Those abridged applications can be generics, hybrids or biosimilars.

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What's the difference between a generic and a hybrid drug? A generic drug is considered to be an exact copy of an already approved drug. A hybrid drug, on the other hand, is changed in some ways while still being based on similar molecules. The tricky part is that you need to find out what you need to do from a regulatory perspective while making sure that it is a fast process as you and your competitors are racing to the line of market approval.  

What we do 

  • Due Diligence of dossiers of in-licensing products.

  • Regulatory strategies for and advise on drug development (including dosage form, excipients, specification settings, stability studies as well as bioequivalence study design and possible biowaivers), legal basis for submission and reference product, regulatory strategy and choice of regulatory procedure (centralised, decentralised, mutual recognition, national).

  • Provide country-specific support in the Nordics.

  • Scientific advice processes.

  • Communicate with competent authorities on behalf of the applicant.

  • Compile CTD, assist in publishing (eCTD) and submission.

  • Product Lifecycle Management.

  • Target product profiles 

  • Regulatory roadmaps

How to begin? A first meeting is a good start 👇

Contact our director of Regulatory Affairs

Send your inquiry to Erika Spens

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