Global Regulatory Strategies

A clear regulatory strategy is vital to the success of any product development plan. 

Each product is different. RApport can help you define strategies for new formulations, new indications, existing or novel products in specific countries, regions or globally. RApport can help you develop strategic tools such as Target Product Profiles and Risk Registers so that you can assess and manage the regulatory risks at each stage of your project. Our support will enable you to stay on the right path, guided by your end vision.

Global Reach

RApport is able to help you define your strategy based on our experience and extensive knowledge of global regulatory pathways and guidance documentation. We will advise you on overall strategy including potential inclusion in early access schemes for example:



Priority review, Breakthrough therapy, Accelerated Approval, Fast-Track


PRIME, Conditional Marketing Approval, Accelerated Assessment, Exceptional Circumstances, BREXIT planning


Standard, Priority review, Sakigake, bridging clinical trial data


Accelerated Approval, Priority review, Acceptability of foreign clinical trial data, CTA review and Approvals


Priority review, Standard review, Notice of Compliance (NOC), Special Access Programmes


Priority review, Provisional Approval pathway, COR’s (assessments from comparable overseas regulators)

Our support will enable you to make a clear regulatory decision on your path to approval. 

We also provide strategic support in many other countries around the globe.

SME Support

RApport has a special interest in providing small and medium size companies (SMEs) with experienced development support. You may have no or limited internal regulatory support – whatever the case, we can work as an integral member of the internal development team to provide as much or as little support as needed to drive your project forward.

As a European SME with an office in the EU we can help non EU SMEs access EMA support, including advice from the SME office and reduced fees for Scientific Advice.

Due Diligence

RApport has extensive experience in many therapeutic areas which enables clear evaluation of opportunities including likelihood of success as well as onboarding products once a deal is complete. Numerous products have been evaluated, the risks assessed and strategic advice provided on the path forward to help companies make the right decision for them.