Precision Pharma Regulatory Services

Precision's Pharma is a team of experienced regulatory affairs consultants who specialize in pharmaceutical and medical device regulatory affairs. They are highly skilled in compiling dossiers for global regulatory authorities in CTD, eCTD, ACTD, and country-specific formats for the CIS Countries, ASEAN, AFRICAN, Middle East, Latin American (Latam), and ROW markets. We provide regulatory framework support to the pharmaceutical and healthcare industries throughout the regulatory chain, from regulatory strategy, intelligence, dossiers, and submissions to post-approval, product maintenance, query resolution, artwork management, and other associated tasks. We offer an effective solution for both short- and long-term regulatory or compliance needs. Our services include, but are not limited to:  Country Specific Dossiers  CTD Dossiers Compilation  ACTD Dossiers Compilation  eCTD Dossiers Compilation eCTD Dossiers submission  ANDA (Abbreviated new drug application)  USFDA product registration  CTD DMF Services  eCTD DMF Services  Site Master Files (SMF)  Comparative Dissolution Profile (CDP)  BE/BA Study  Query Resolution  Stability Study Reports  Artwork Management  Risk Management Plan (RMP)  Periodic safety update report (PSUR)  Analytical Method Validation (AMV)  Product Development Report (PDR)  Process validation Report (PV)  SOP preparation  Preparation of documents and Audit as per WHO/GMP guidelines We are now working with a variety of small to large-scale firms to provide regulatory services for securing approval or registration of their products in global markets, and we are extremely eager to serve you and your organization!