Regulatory Due Diligence
Acquisition of new products to portfolio from a third party is a popular business model in current pharmaceutical and cosmetic industry. Instead of developing a new pharmaceutical product, supplement, cosmetic or medical device themselves, it is often more efficient to acquire a product with Marketing Authorisation from a third party. The new product or therapeutic solution acquired to the portfolio should be carefully analyzed in terms of scientific data, registration documentation, position against competing products and other product-specific aspects. Failure to analyze critical aspects may have serious consequences in commercializing the product. In general, before investment decision, it is worth conducting Regulatory Due Diligence analysis which include determination whether product of interest is truly marketable in terms of regulatory point of view.
Why SciencePharma?
At Science Pharma, we have participated in dozens of projects related to pharmaceutical products, medical devices as well as cosmetics and dietary supplements at various stages of development, supporting our clients and partners in their development. We assist our clients in paving a straightforward regulatory path through all development activities and we can easily estimate the product, point out potential disadvantages as well as obstacles which may be crucial for the commercialization of the product.
Our experienced experts are able to effectively evaluate pharmaceutical products, medical devices, cosmetics or dietary supplements and their documentations as well as identify potentially sensitive issues affecting the further development of the product or market launch. Regulatory Due Diligence analysis is therefore the first step in the new product acquisition.
Our support may include
- Carring out a regulatory evaluation of the project, including:
- gap analysis of current data (Modules 1-5 assessment, if already available),
- pointing out critical aspects and deficiencies of the project
- troubleshooting in the way to propose ways of action, problem solving.
- Indicating the appropriate registration pathway and related costs.
- Determining the full range of needed developmental studies, including CMC (chemical, manufacturing and controlling) and non-clinical studies as well as clinical trials.
- Estimating the development costs of the next stages.
- Estimating the advancement of the project and point out scientific and technological risks associated with its further developmental steps, as well as mitigation proposals.
- Competitive landscape analysis and comparing the project (or developed solution) with existing products/services supplying the same need or other competitive products/services under development.
- Assistance in finding additional public subsidy for the project under development, if required.
If you are planning to purchase a new pharmaceutical product, medical device, cosmetic or dietary supplement, we can support you in making the final business decision by conducting Regulatory Due Diligence Analysis.