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Case Study:

Regulatory Affairs #2

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Client:

Large BioPharmaceutical company based in NJ and Southern California.

Key Issues:

Our client was going through a large scale merger that resulted in a full hiring freeze across the many of the functional groups, including Regulatory Affairs. Due to the aggressive submission schedule, the timing of the acquisition was especially taxing on the Regulatory CMC team, because they were also preparing for a large tech transfer to a new manufacturer in the UK.

Solution:

BioPoint worked with our client to understand their challenges, metrics and time lines across several different Regulatory groups including: Regulatory CMC, Labeling, Submissions and Strategy.

We then assembled a team to properly support our clients Regulatory teams with their resource requirements. Consultants performed tasks such as: implementation and completion of Tech transfer and validation plans while conforming to various health agencies(FDA/EMA/HC/ROW), Submissions strategy and broad writing support (NDA,sNDA,MAA,CTA), update CCDS, global label harmonization, authoring CMC modules 2.3 and 3 as well as post approval CMC changes/variations across multiple countries.

Conclusion:

BioPoint’s team was integral in helping our client meet its submissions deadlines, tech transfer and other project milestones by assembling a virtual team of 38 total Regulatory Consultants across a wide range of strategic/tactical regulatory focus areas. Additionally, when the hiring freeze was lifted the client was able to transition 6 individuals from the BioPoint team to become permanent employees. The majority of the BioPoint team remained engaged to help successfully transition the project work to new FTE entering the organization.