Early Stage Diligence

May be fast (a quick look and done), or last up to a few years and have repetitive evaluations of the same target as more data becomes available.

  1. Business Development /Search & Evaluation looks at a high volume of potential targets throughout the year, evaluating for therapeutic modality/technical fit, in vitro, animal or early clinical proof of concept, early signs of safety & efficacy, alignment with the operating model, Financials, and competitive landscape, along with risks such as IP issues, Legal challenges, and structural aspects of a potential deal.

  2. Quality is usually not involved in these fast-and-frequent evaluations.

3. The Due Diligence team expands to include additional functions such as R&D, Operations/CMC, HR, Finance, Procurement, IT, Legal, Regulatory, and hopefully Quality.

4. Functions evaluate the target according to their expertise, interacting together to review the target, potentially identify “Deal-Breakers” and anticipate operational challenges should the Deal come to pass.

5. Deal-Breakers in the Quality realm may include data-integrity issues (unable to trust the data the target company or their vendors are providing), use of unreliable vendors or disrupted supply chain, CMC issues with the manufacturing or quality of the product(s). Quality issues can often interrelate with issues found by R&D, Operations, or Regulatory. P3R helps identify these issues.

6. In addition to technical /due diligence aspects, financial “synergies” are evaluated for how the acquiring company can accelerate clinical or commercial development of the incoming asset(s), overcome regulatory hurdles, launch the product(s) in more countries, or reduce the cost of goods (COGs) with their own supplier network. “Synergy” can be a scary word for the incoming employees, but should yield positive business results in the long term. P3R can help with Synergy Evaluation from a QMS perspective, such as reducing software licenses, simplification of the QMS, and consolidation of systems and data.

7. This is the perfect time to engage P3R Quality on your Due Diligence team! We can comb through the Data Room and supplement your Team’s expertise with an independent look.

Confirmatory Diligence/Late Stage Diligence

May last from 1 to 6 months and be impacted by expected clinical read-outs or Financial /Investor pressures on the Deal.