Integrity.
Excellence.
Dedication.

For small and medium-sized companies with novel products, developing a new medicine can seem .

High cost, high risk and high expectations. Is that familiar?

A clear regulatory strategy and trusted team are a vital foundation to achieving success.

InsideReg supports early phase clients developing innovative products, identifying and managing risks, creating regulatory strategies and technical roadmaps that perfectly align with your company objectives, to ensure the correct data is generated in a streamlined manner.

Our multi-disciplinary teams support all aspects of the development programme, ensuring a right-first time and on-time submission of that first clinical trial application, culminating in regulatory approval.

Innovation is exciting. But with guidance and regulations lagging technical advances, it is often venturing into the unknown. This is a journey never taken alone. You are supported not only by our expert consulting teams, highly skilled in identifying the potential challenges early in development, raising them for productive brainstorming sessions and collaborative solution-finding, but also the regulatory authorities.

Now that product safety has been established, we can focus on demonstrating efficacy and utilising several regulatory initiatives, which can also be value-adding from an investment perspective.

Our experts have many years of experience in helping clients access the Orphan Drug Designation, Break-Through Therapy and PRIME schemes offered by the FDA, EMA, MHRA and Swissmedic.

We also support clients with the preparation and submission of the PIP, for which a deferral or waiver is due by the end of Phase 2 in the EU, and shortly after the EOP2 meeting in the USA.

Thereafter, we continue to support our clients throughout Phase 2 with ongoing activities such as clinical study design, substantial and non-substantial amendments to clinical trial applications, scientific advice meetings and due diligence.

The route from Phase 3 to marketing authorisation is complex, highly administrative and each step must be properly executed. As with all the steps on the journey so far, careful and thorough preparation and planning continues to be key.

As an existing client, the consulting team will have acquired significant knowledge and understanding of your product by now. However, should you join us as a new client at this phase of your journey, be assured we have the knowledge and expertise to quickly learn about your product, enabling us to author the necessary regulatory documentation efficiently.

Our expert teams have many years’ experience of authoring and submitting MAA/BLA/NDA applications for small molecules, biological and innovative products. We advise on timelines, mandatory steps in the procedures and how best to position all the data generated, advising on likely questions, risk mitigation strategies and response preparation.

Finally, our excellent relationships with the regulatory authorities mean that communication is clear and transparent, and the procedure progresses smoothly.

With our expert, collective team behind you and clear planning, the route to MAA/BLA/NDA approval becomes a series of manageable steps, easily accomplished and builds towards that all important approval and launch date.