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Compliance group urgently needed for quality control process


Urgent need for FDA compliance group

A PE firm’s principal of operations came to us with a critical need for a compliance group that could help them assess a target pharmaceutical manufacturing company’s FDA-certified quality control process. Working on a fragile deal, the firm needed an expert provider who could assess the company’s processes in order to ensure they were well-documented, identify if there could be issues in the future given where the FDA was going, and note if the results from a recent FDA inspection were kosher. The firm needed the provider to be PE-grade, understand the pharmaceutical space, and be enough of an expert to also provide recommendations as they performed the audit.

BluWave finds exact-fit provider to match firm’s needs

Leveraging our founder’s 20 years in private equity, we have extensive frameworks for assessing PE-grade compliance & regulatory needs. BluWave utilizes technology, data, and human ingenuity to pre-map, assess, monitor, and maintain deep pools of compliance & regulatory groups as well as independent consultants that uniquely meet the private equity standard. We interviewed the PE firm to understand their specific key criteria, and then connected the client with a select pre-vetted provider from our invitation-only Intelligent Network that fit their exacting needs.

Firm engages presented provider to conduct quality control

Within less than 24 hours of the initial scoping call, the PE firm was introduced to an exact-fit PE-grade compliance group that specialized in assessing FDA quality control processes .The PE firm confidently engaged the provider to conduct the audit. Thanks to the provider’s work, the firm was able to gain the insights they needed on the current state and needed improvements of the target’s processes in order to move forward with the deal.

“The compliance group brought to us by BluWave was exactly what we needed and had the references that allowed us to feel confident about quickly engaging the provider and moving forward with our deal.”

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