Regulatory Services for Complete Clinical Continuum

The clinical journey of a new product is often difficult and lengthy. It involves preclinical development, clinical trials, regulatory submissions and finally regulatory approval to market the product. The most tedious and stringent of all these is regulatory affairs. Regulatory bodies have become stricter than before and are constantly evolving guidelines and regulations for the betterment of mankind. At Pharma Professional Services, we understand the nuances of complex regulatory requirements and offer regulatory support to Pharma and Biotech companies at every stage of their clinical development.Our Regulatory Affairs (RA) department in co-operation with our international network of regulatory affairs professionals, facilitateregulatory solutions for drug or device at every stage.

CTD – Dossiers

One of the most important part of any registration application for Marketing Authorization is Common Technical Document (Product Dossier). It needs to be compiled in CTD Format/ ACTD Format or local country format for its submission to Food & Drug Authority (FDA) or Ministry of health (MOH) or any other equivalent authority. In addition to CTD, other technical documents and legal manufacturing permissions are also required for market authorization. We, at Pharma Professional Services understand the complexity of this task and can help you in preparing the entire registration file for drug product registration around the globe..