Line of Business (LOB)

LOB 1: Formulation

LOB 2: Consulting

Background

Non-EU client wanted to formulate an out of patent generic for registration with the EU to capitalize on the market share.

Client Challenges

  • Limited knowledge of generic product formulation.
  • Limited knowledge of generic product registration in EU.

Solution provided by PLG

  • Developed the product successfully for the client, assisted them during the technology transfer.
  • Selected the CRO for the BE study and monitored the study.
  • Performed GMP inspection at the manufacturing site and provided guidance for site compliance.
  • Provided the regulatory strategy for the product registration (recommendation on type of procedure and countries to select) and acted as applicant in the DCP.
  • Besides taking care of the whole Dossier writing (M1-5), handled the submission management and provided all the additional required services, such as Pharmacovigilance services, BR/BT, eCTD creation, translations, and the Readability Testing.

Benefits

  • Providing most of the expertise and resources for development and consultation allowed client to focus on other technical aspects of the project.
  • Outsourcing the full management of registration lead to the quickest route to obtaining licenses.

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Formulation and Registration of Generic Product in EU – Phloroglucinol, Fukang