DUE DILIGENCE
Understand the Risks to Make an Informed Decision about Potential Investments
When a company decides to grow its drug product or device portfolio, they can decide to develop the product internally or acquire it in a shorter time by acquisition.
We help companies make informed decisions by impartially conducting a full-fledged due diligence evaluation to assess risk. Other situations where due diligence is crucial is when deciding to invest in a life science company. You need to know what you are getting into before you take that leap of faith. We apply the same rigor and identify what gaps there are and what potential risk there could be.
SERVICE OVERVIEW
Due Diligence Evaluation and Risk Assessment
At Ayd Group, our due diligence approach involves working with clients to understand the reason for the due diligence, as well as particular areas of focus, the depth of assessment and the timelines. We partner with our clients to impartially assess the strengths and weaknesses of target companies’ product development efforts, R&D pipeline, commercial portfolio and regulatory risk associated with any existing compliance issues and/or escalation of FDA enforcement. Through our Alliance partners, we undertake additional aspects of due diligence, including preclinical, clinical and manufacturing. We start with an initial review of information available to gain an understanding of the expertise required. Then, we select a team of technical evaluators who are matched to the client’s needs. We report our findings in a risk assessment dashboard, enabling our clients to see quickly where any risks lie.
We offer Due Diligence Evaluation and Risk Assessment services for:
- Research & Development Operation
- Gap analysis/regulatory risk assessment
- Laboratory/facilities compliance issues
- R&D pipeline CMC issues
- Commercial Portfolio
- Gap analysis/regulatory risk assessment
- Complete Response Letter (CRL) implications for drugs pending commercial approval
- FDA 483s and FDA warning letter implications on future approvals
- Remediation effort time and cost assessment
- Preclinical & Clinical
- Gap analysis/regulatory risk assessment
- Clinical holds
- Manufacturing
- FDA 483s and warning letter implications on future approvals
- Remediation effort time and cost assessment
CASE STUDY
Internal Due Diligence — Understanding Your Company’s Shortfalls before Others Find Them
Sample Engagements
Due diligence on R&D drug pipeline and commercial portfolio a $1B public, US life science company seeking to put itself up for acquisition. Devised a simplified “score card” approach to assess various types of risk. Developed selection criteria to enable a deep dive on only a portion of 100+ drug codes, but represent all. Presented findings to the Board and provided additional support in determining a portfolio value. Client was acquired and taken private.
Assisted a US company in finding and qualifying a Contract Development & Manufacturing Organization (CDMO) where they could transfer technology for an imaging agent. Currently assisting client with CMC support/assembling the CMC using CDMO-provided details.
A not-for-profit (NFP) Women’s Health Pharmaceutical company’s leading branded product’s patents were to expire within the next few years. The company’s Board tasked the leadership team to come up with a defensive lifecycle management strategy. Ayd Group was retained to develop a justification for them in the event they decided to expand operations to include a generic drug business unit. After a lengthy and complex process that factored in the company’s mission-statement, it was determined that generic market entry was feasible. The company would continue to focus on developing additional branded products, but would now have a business unit focused on complementary generic drugs focused on women’s health. Ayd group delivered a detailed evaluation report. We provided specific recommendations on what types of generic products their portfolio should include and what channels are best suited for marketing, sales and distribution. We also were able to determine who their competition is likely to be and described how they would need to transform from an internal perspective to be competitive.
A $900M privately held US-based generic drug company sought to expand its business by acquisition. Support that was provided to the client included a review of regulatory documents, as well as a mock GMP facility inspection. For drugs still under development, only the product development report was evaluated. For products pending FDA review, the communication sequence and history was evaluated. Two facilities were inspected: one already FDA-inspected and one not yet on line. Plant operations were primarily aseptic fill and terminal sterilization. One facility was ~$200,000 sq. ft., and the other ~$125,000 sq. ft. Ayd Group issued a written report of findings to company /client CEO.
Minimize the Uncertainties Before You Take the Leap.
We bring impartiality to assessing the strengths and weaknesses of investment opportunities. Let’s talk about how Ayd Group can help minimize the risk.