by Prakash Achaary | May 21, 2021 | Blog
[Fill out the form below to register] Abstract: When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be challenging and creating scientifically-sound strategies are...
by Prakash Achaary | May 21, 2021 | Blog
Regulatory document quality is of the utmost importance in the pharmaceutical, biotechnology, and medical device industries to ensure data accuracy and provide confidence in drawing reliable conclusions. A great quality control process ensures that the writing is...
by Prakash Achaary | May 12, 2021 | Blog
The European Medicines Agency (EMA) recently announced the European Union (EU) Portal, a database for obtaining a clinical trial authorization, will be activated by the end of January 2022. The EU Portal will trigger the enforcement of the EU Clinical Trial...
by Prakash Achaary | Aug 27, 2020 | Blog
[Fill out the form below to access the whitepaper] The Orphan Drug Act, established in 1983, provides incentives to sponsors for promoting the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than...
by Prakash Achaary | Aug 18, 2020 | News
Uttar Pradesh, India (August 18, 2020) – MMS Holdings Inc. (MMS) – an award-winning, data-focused and technology-enabled CRO – announced today that Maharana Pratap Group of Institutions (MPGI) has partnered with MMS Academy, the learning arm of MMS. In the...