An example of our services in feasibility and due-diligence is when a client is considering licensing in a novel product, for which in-house expertise may not be available to assess the regulatory implications of that product. ERA can provide a report on the current status of the project, regulatory hurdles to be overcome, the work that will be required and the likely timelines to submission of a dossier.
With our accumulated experience, the ERA team can help clients to evaluate business opportunities for novel biotech/biological products, either in the area of acquisitions and mergers, or in the licensing of new products. We hope to add value to such activities, possibly by detecting significant flaws, thereby saving our client considerable time and money.
Services in this context can include the following:
Product licensing or co-development
- Status of product development and assessment of product development strategy
- Regulatory hurdles and perspectives for marketing authorisation
Company mergers and acquisitions
- Regulatory status of the company’s product portfolio
- Regulatory implications of the product pipeline
- Regulatory implications of alternative production processes or expression systems
- Opportunities relating to multisource products