Case Studies - Therainnova

We are always
on the move

Case Studies

“therainnova: Supporting Biopharmaceutical Companies with Regulatory Expertise”

At therainnova, we offer a range of support services to bio pharmaceutical clients, as well as companies and investors in need of regulatory due diligence support. Our case studies highlight the specific ways in which we can assist our clients in navigating the complex regulatory landscape.

We are always
on the move

Case Studies

therainnova provides support to biotech and pharmaceutical and clients, as well as companies and investors conducting regulatory due diligence. The below selection of regulatory case studies outlines the typical support we provide.

Case Study 01

Navigating the EU Regulatory Environment

Our client is a biotechnology company that has recently entered phase II clinical studies for a medicinal product for a rare disease. They were seeking guidance on how to navigate the EU regulatory environment to ensure that their product could be registered in the future.

Case Study 02

Interim Head of Regulatory Affairs

The client did not have a dedicated regulatory affairs department, and they needed support in submitting a Marketing Authorisation Application (MAA). They sought consultancy support to set up a filing plan and lead a cross-functional team through the filing process.

Case Study 03

International Registration

The client, a small US-based company, had developed a medicinal product for a high unmet medical need. They were considering participating in an international programme to file for registration in multiple countries in parallel.

Case Study 04

Strategic Regulatory Advice, Health Authority Interactions and Submission Management

The client is a small US-based company that has set up an affiliate in Europe and been granted SME status. The company wishes to file an Orphan Designation in Europe and benefit from the SME incentives offered for this process. They require strategic EU regulatory support, publishing assistance, and help setting up EU submission portals.