Whether you seek expert regulatory advice for regulatory starting materials selection, identifying control strategies for genotoxic impurities, or help in strategizing and preparing briefing documents or CTD Modules 3 and 2 of regulatory submissions, we have qualified professionals to support your specific regulatory requirements. Our staff comes from the pharma industry and the FDA, with proven expertise in all areas of CMC Regulatory Affairs to support global clinical trials and market authorization applications. We are adept in designing phase appropriate and product specific CMC strategies that are the key to successful and expedited drug development.

Typically, regulatory activities follow the 80:20 rule, i.e. 80% are tactical and 20% are strategic. USV offers both strategic and tactical CMC solutions. Strategic CMC regulatory solutions are designed on a case-by-case basis by evaluating the scientific and technical situation and challenges whereas tactical solutions are primarily geared towards the execution of the strategy.

MEDATEQ LABS offer services like, Regulatory compliance ( For Ex: Health authorities approved product information Vs what was actually implementing at the manufacturing plant level), manufacturing plant Auditing, corrective and preventive action (CAPA) management, computerized system validation, manufacturing equipment validation, IT system implementation, laboratory instrument validation, Mock up audits to help in identify continuous improvement opportunities within their quality systems.

MEDATEQ LABS conducts third party audits like vendors of active substance, formulations, excipients, packing materials etc to ensure vendor compliance to the purchase specified regulatory standards. Whatever may be your requirements; our professional team of qualified auditors with experience will apply their technical expertise to ensure vendor compliance to ISO, UK-MHRA, MCC, TGA, in house or other standards as required by you. Such audits, conducted periodically, will help to maintain good relationship between the suppliers and buyers