https://biotherapypartners.com/tag/cell-therapy/ Commited to your success Tue, 25 Jul 2023 17:26:51 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.2 https://biotherapypartners.com/wp-content/uploads/2022/12/cropped-logo_site_mini-32x32.png https://biotherapypartners.com/tag/cell-therapy/ 32 32 https://biotherapypartners.com/support-for-the-preparation-of-an-ind-package/ Wed, 07 Jun 2023 15:15:23 +0000 https://biotherapypartners.fr/?p=1545 Read more]]> The request

A biotech startup requested a support to review, supplement and complete the necessary documentation for a clinical trial application

Biotherapy Partners approach

A review of the existing documentation was acomplished, a gap analysis was done, additional studies were performed if necessary, reports were written, the dossier for clininical trial application was prepared filed to regulatory agency, questions from the agency were answered and the clinical trial was initiated.

Results

BP identified the gaps, proposed supplementary studies and contributed to finalize a successful clinicical trial application for FDA.

]]> https://biotherapypartners.com/due-diligence-for-cell-therapy/ Mon, 15 May 2023 17:52:13 +0000 https://biotherapypartners.fr/?p=1357 Read more]]> The request

Client was looking to complement its internal team with seasoned experts in cell therapy.

Biotherapy Partners approach

BP reviewed existing data, focussing on critical, potentially deal-breaking data and interacts with third-party SMEs.

Results

BP pintpointed during due diligence key success factors for the deal & next steps.

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