MC specializes in providing end to end regulatory solutions across different regulatory verticals – Pharmaceuticals, Generics, Medical Devices. Our expert team has in-depth regulatory knowledge with complete understanding of the complex processes and experience in multiple therapeutic areas.
With a qualified team of skilled medical writing professionals from clinical research industries, MC has the capabilities to develop quality documents, review and coordinate with clients and authorities to generate required writing activities in both Electronic Common Technical Document (eCTD) and CTD modules. We cater to the needs of various regional Health Authorities of US, EU, Middle East, Japan, Canada, and India. MC also has experience in developing Canadian Annual Summary Reports (CAR), post-marketing surveillance (PMS) plans and generating Periodic Safety Update Reports (PSURs) as a part of regulatory services. We have defined processes for generating submission ready documents in terms of technical information, language, formats, and templates used. We strictly follow guidelines and timely delivery with highest standards of quality.