Regulatory work starts together with the product development. We can support your R&D / clinical and marketing teams to form a right regulatory strategy right from the concept stage which will help your company to ‘register your product right first time’.
Forming a regulatory strategy already during the feasibility stage will help speed up the registration of your product through efficient utilisation of registration procedures.
We help you to establish the regulatory strategy by:
- Classification
- Define the regulatory pathway for the submission
- Identify the risks associated with the submission
- Mitigation of risks to streamline the process