We're adept in our understanding of all regulatory protocols surrounding a medicines development.
We're adept in our understanding of all regulatory protocols surrounding a medicines development.
Regulatory Affairs
It can take 10-15 years for a medicine to progress through the entire development and there are significant amounts of legislation in place to ensure the treatment is as safe and efficacious as possible.
At Assion we are adept in our understanding of all the regulatory rules surrounding drug development, registration, and maintenance. Our expertise and know-how ensure that these are adhered to at each stage of product lifecycle.
Assion’s regulatory experts work with our clients to provide a strategic analysis of their project. Our approach encompasses a gap analysis based on the most current regulatory requirements together with the necessary actions. Our areas of support include:
- Development and Regulatory Strategic Advice
- Interactions with the Regulatory Authorities
- Preparation of the registration dossier
- Management of the registration procedures
- Life cycle management
On demand regulatory team an Assion case study
A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.