Regulatory Affairs Services

Fast and efficient market approval without compromised quality

At SDS Life Science, we know that many drug development projects fail due to either running out of time or funding, not being adequately prepared before interacting with the authorities, or due to study design-related mistakes. Not because the idea itself is scientifically bad. It’s probably not.

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Are you doing the right things at the right time?

Imagine this. You’re at the top of the game regarding the details and science behind the drug itself. Now, without doing the right things at the right time, your project might be at risk of not gaining regulatory approval. At the end of the day, patients will not receive the help they need in the form of your intended treatment. Or they will not receive it in time. This is where we help.

Services that get you closer to market approval

Our services within regulatory affairs ensure an increased chance of reaching market approval while avoiding unnecessary delays. We evaluate any opportunities for ‘’expedited pathways’’, a technical term for various regulatory fast-tracking possibilities intended to reduce time to market significantly.

Services

Communication with regulatory authorities - A crucial part of drug development

Discussions with regulatory authorities can be held at any time during the drug development process. National European authorities, EMA, FDA, and PMDA (Japan), for example, offer different kinds of scientific advice meetings to respond to specific questions by the drug developer.

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Regulatory roadmap - Define your ''drug route to market''

A regulatory roadmap is a powerful strategic document that identifies and summarizes the ''drug route to market''. It is exceptionally useful for developers to manage stakeholder relations such as investors, stockholders and potential collaboration partners.

Services

Preparation and coordination of submissions

We can support you in preparing documents, compiling submissions and coordinating the review process. The pre-submission activities include for example pediatric plans (PIP/PSP), requests for Orphan Drug Designation, Fast Track, Breakthrough Therapy Designation and PRIME.

Services

Abridged applications for generics and hybrids

When the data exclusivity period for a medicinal product expires, it opens up the possibility for other companies to register their products based on the data from the original product. These abridged applications can be submitted through the generic, hybrid or biosimilar regulatory paths.

What happens at our first meeting? 🤔

Our first meeting intends to get a mutual understanding of your need for strategic services and/or operational support. The initial meeting is also a splendid opportunity to ask a regulatory expert any questions you like. This is the first step towards sending you an initial business proposal draft.

The first meeting is entirely free of charge. So don’t hesitate to send us an email or give us a call.

Contact our director of Regulatory Affairs

Send an inquiry to Erika Spens

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