Shreya Patel Email & Phone Number

Strong knowledge of International Regulatory Affairs, submission and approval process of Drug (IND, NDA, ANDA) and medical device (510K, PMA, IVD). Understanding of FDA, IRB, MHRA, ICH, EU guidance and brief knowledge of GXP, drug development, product labeling, packing and post-marketing surveillance Basic knowledge of SAS application and Good laboratory practices. (GLP)Excellent oral and written communication skills & capability to adapt and learn new tools and applications.cGMP – Preparing, reviewing and implementation of cGMP documents, drug product disposition and approval of COA. SOP, Batch manufacturing records, Validation protocols, Qualification Documents, Analytical DocumentsConduct Audit- intern departments, Conduct Audit for Toxicology sitesProficient in computer and software skills (Word, Excel, PowerPoint, Outlook), Assist LIMS and Veeva Docs Quality system

Listed skills include Project Work, Clinical Trials, Chemical, Tlc, and 123 others.