Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the 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, interacting with FDA Divisions and building global development programs. We work collaboratively with our clients to provide embedded or virtual solutions by integrating seamlessly into product teams, advising senior management and mentoring staff.
Advyzom also provides medical writing and submissions services. Our Medical and Scientific Writing experts can author a broad range of clinical and non-clinical documents and publications needed throughout a product’s development and for global regulatory submissions. The Operations and Submissions experts have an approved FDA gateway and use validated eCTD software to perform client IND, NDA/BLA and pharmacovigilance to the FDA, as well as submitting advertisement and promotional materials to the Office of Prescription and Drug Promotion (OPDP).