Given the unique nature of the biotechnology business with its very long product development cycle, high financial investments and its multifactor risk environment, due diligence in the biotechnology and R&D pharmaceutical fields require detailed analysis of the project, aimed to identify any problems within the product development plan, especially those with the potential to result in future liabilities.
Our in-depth knowledge of the regulatory framework and the health products market dynamics, as well as our extensive experience with all phases of the product development cycle, allow us to identify and locate the company’s assets as well as to come across possible project weaknesses and limitations.
B.R.D. offers scientific and regulatory due diligence & valuation services to avoid costly mistakes, with a focus on the ability to customize the development process and secure potential investment viability.
Our project evaluation provides:
- Expert reports for R&D projects assessment to cover all phases of the existing product development information including: CMC, pre-clinical and clinical development.
- Assessment of regulatory compliance of the product development process.
- Regulatory expert reports for early stage investments or acquisition
- Project selection opinion
- Regulatory opinion regarding the strategy product development plan
- Preparation of scientific and regulatory sections for company business plans
- Preparation of R&D budget to cover regulatory needs