Line of Business (LOB)

LOB 1: Due Diligence of Non-Clinical, Clinical and CMC data

LOB 2: EU GMP Inspection with added guidance

LOB 3: Product Development Plan and EU Registration Strategy

LOB 4: Scientific Advice Meeting

Background

Non-EU client wanted to register a new biological drug in EU. The proposed product was already registered in some Asian countries.

Client Challenges

  • Very few EU agencies had experience of providing advice on any similar product and indication, so choice of agency for SAM was difficult.
  • All the data (non-clinical and clinical) generated by the client was non-EU data, but the client had intention of obtaining waiver for few studies.
  • Very few EU agencies had experience of providing advice on any similar product and indication, so choice of agency for SAM was difficult.
  • All the data (non-clinical and clinical) generated by the client was non-EU data, but the client had intention of obtaining waiver for few studies.

Solution provided by PLG

Collected possible pre-clinical/clinical intelligence via network of ex-agency assessors, suggested the best possible indication and relevant endpoints for the planned clinical studies.

Chose an appropriate agency for SA meeting, drafted required documents and presentation for the SAM and provided full participation on behalf of the client.

In the SAM, the client received the required clarity on their development plan and was satisfied with the meeting outcome.

Selected and qualified CROs in the right countries for the proposed studies and prepared a costing plan.

Benefits

Rapid collection of industry data from ex-assessors, saved the client both time and money.

Accuracy in choosing the most appropriate agency with the best expertise for the specific product type.

Experience in selecting a CRO, balancing the client’s cost-benefit for recommended studies.

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New Biological Drug – Ulinastatin, Techpool