Due diligence

Clinmark conducted over 40 major due diligence assignments for large pharma, biotech enterprises, and investors, underpinned by our ability to draw in expert consultants who are masters in each major discipline involved in healthcare R&D.

We undertake all aspects of technical, opportunity and scientific due diligence, including science/technology platforms, intellectual property, preclinical and clinical development, regulatory due diligence, pharmaceutical development and manufacturing, commercial and medical affairs.

Our expert network allows us to rapidly assemble due diligence teams that incorporate consultants with precisely the expertise each project requires, across a wide range of product modalities, functional disciplines and disease areas.

Our activities frequently include:

  •  An initial review of data to gain an understanding of materials available and expertise required
  •  Pre-DD assessment to identify any “red flag” areas
  •  Selecting and deploying teams of technical evaluators matched to the client’s need, and supplementing with primary and secondary research
  •  Reporting our findings in a risk assessment dashboard, enabling our client to quickly identify where key risks and mitigation opportunities lie
  •  Providing an opinion on whether the company or asset faces lower or higher than average risk, compared to industry averages

We support biotech companies to help them acquire new technology or to operate effectively in the EU if they do not have a legal presence in Europe.

Our team can use its extensive experience to assist clients in planning and executing their development programs, by providing strategic input and advising on or building an overall development plan for the product from concept, through pre-clinical development, to first-in-human and later-stage clinical studies, through to registration and beyond. Operationally, our team works closely with clients to oversee an agreed program or work, which may cover all aspects of development, including manufacturing and analytical characterization, pre-clinical studies and regulatory activities.

Our experience with advanced therapies enables us to innovate when faced with novel situations for which there may be no obvious development or regulatory precedent.

For clients considering an investment, partnership or licensing agreement for a medicinal product with a view to developing or marketing it, we can help with the assessment of value.

We work hard to scrutinize the relevant data for the product and reports the findings to highlight areas of concern and likely additional work that will be required to obtain licensure and commercialization.

Our balanced scientific approach, in-depth knowledge of the EU regulatory environment and years of experience at all stages of product development will help ensure there are no surprises when the deal is done.

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