Advyzom is a leading boutique consulting company specializing in highly strategic regulatory/US Agent and development advice by offering services for our partner companies in the biotechnology, pharmaceutical and healthcare industry.
We are recognized insightful leaders who seek and create opportunities throughout the product lifecycle to ensure each client’s asset is successfully transformed into a valuable therapy for patients. Our experienced Regulatory Strategy team has successfully navigated across therapeutic areas and technologies, interacting with Health Authorities and building global development programs with our innovative clients. We partner with companies working collaboratively to provide regulatory solutions by integrating seamlessly into product teams, advising senior management and/or mentoring staff. Advyzom also provides medical writing and submissions services.
Our Medical and Scientific Writing scientific experts can author a broad range of clinical and non-clinical documents, Health Authorities briefing packages, high level IND/NDA/BLA/MAA summaries, Fast Track and Breakthrough designations, pediatric plans, orphan drug designations and publications needed throughout a product’s development and for regulatory submissions. The Operations and Submissions experts have an approved FDA gateway and use validated eCTD software to submit IND’s, NDA/BLA’s and advertisement and promotional materials to FDA. Additionally, we can build a global eCTD to allow for filings in Europe and/or rest of world.