Under Quality Assurance and Quality Control department well qualified and experienced personal takes care of regulatory work. We are capable of supporting registration process and other regulatory documentation as per the needs of concern country. We support our associate by providing dossiers as per CTD, ACTD and country specific guidelines. We have several dossiers ready for fast pace product registration.
Our facilities are constantly upgraded to comply with CGMP norms. Formulation development cell is engaged in new formulation development on regular basis. Routinely internal audits are carried out for constant upgradation of facility and procedures to meet contemporary international quality standards. Deviations in process and products are recorded and promptly complied.
The regulatory affairs team plays a key role in getting the products of Trugen’s registered in global markets and prepare the technical data for all the country. Our team of regulatory experts are dedicated to help our customers with regulatory questions and to support them with their regulatory submissions. Globally Pharma industry is growing rapidly. Thus the regulatory plays a very important role due to change of government regulations and policies. Regulatory Affairs department is a vital bridge between manufacturing and marketing departments and it involves various processes. Our Highly qualified and experienced regulatory professionals ensure necessary documentation, licensing and legal compliances before the products are allowed to enter the market.