Propharmex

CMC Authoring and Publishing

At Propharmex, we recognize and understand scientific and regulatory complexity behind pharmaceutical products and regulatory requirements. Our team streamlines data based on the regulatory pathway and jurisdiction to ensure clarity, compliance, and accuracy.

We specialize in high-quality CMC authoring and regulatory strategy by following robust documentation standards and a meticulous review process from early Product development stages to market access and support entire product lifecycle, providing end-to-end regulatory solutions that accelerate your path to market (With successful track record of obtaining Health Canada approvals in a short span of 6 – 9 months). We tailor data presentation to suit the product type and application requirements ensuring accuracy, compliance and efficiency.

Our expertise spans a broad spectrum of product types including: Active Pharmaceutical Ingredients (APIs), Biologics and biosimilars, Complex molecules, Small molecules, Medical Devices, Natural Health Products and Over The Counter (OTC).
 
Regulatory Publishing
Propharmex remains fully aligned with all current Health Canada guidelines and Global regulatory requirements to ensure efficient and timely product approvals.
 
We operate using the electronic Common Technical Document (eCTD) format across a wide range of submission types supporting major markets through CESG gateway (US, Europe, Canada, Australia & South Africa), NeeS, country-specific dossier submission and ASEAN Common Technical Dossier (ACTD) formats