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About Imbolc Pharma Consulting

Regulatory Agency interactions are critical steps in your drug development journey and should not be taken without preparation. Scientific legislation and guidelines can be difficult to navigate; it can be challenging to understand how much leeway will be allowed and how to draft documents to ensure they are acceptable to Agency reviewers. Submitting documentation that leads to questions from the Agency costs you time and money, and sometimes those questions are simply a result of the reviewer not understanding the work you have done. Imbolc Pharma Consulting supports pharma and biotech companies to get the best outcome from Agency interactions, from scientific advice procedures, clinical trial applications, and marketing authorisation applications to post-approval variations/ renewals. We do this by assessing the available information with a reviewer's eye, looking for potential questions and addressing them upfront. We also support with ore general CMC / Regulatory strategy and due diligence. Comprised of ex-Agency reviewers and with over 10 years in the regulatory consulting arena, Imbolc Pharma Consulting offers a wealth of expertise covering the development lifecycle. We understand how the reviewers think and how to draft documents and position arguments to ensure the most favourable outcome. Contact us to see how we can support you with your drug development journey

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