➤ What we do ➤ Regulatory ➤ Regulatory strategy support

Regulatory strategy support

Regulatory assesments

Why we do this:

This involves analysing the relevant regulations and standards that apply to either a product or service. We work with clients to identify the appropriate regulatory requirements and assess the level of regulatory risk associated with the product or service.

Regulatory planning

Why we do this:

Once the regulatory requirements have been identified, we can help clients to develop a regulatory plan. This plan will outline the regulatory pathway for the product or service, including the types of regulatory submissions that will be required and the timelines for each submission.

Keeping up to date

Why we do this:

As regulations change and evolve, our team will update the regulatory strategy to ensure that the products remain compliant. This may involve updating the regulatory plan, preparing new submissions, or making changes to the product to ensure ongoing compliance.

Regulatory compliance

Why we do this:

After the product has been approved for market, our team can provide ongoing regulatory compliance support. This involves ensuring that the product continues to comply with regulatory requirements, including ongoing monitoring and reporting of adverse events.