Regulatory Compliance

Medec has a dedicated regulatory affairs department responsible for the registration of products in various countries. Our team of regulatory affairs experts plays a pivotal role from initiation to completion of the project ensuring compliance with applicable laws and regulations throughout the process. We have successfully submitted numerous dossiers for regulated and semi-regulated markets.

At Medec we believe in “Excellence through Quality”. Medec Adheres to strict quality parameters in the manufacturing and distribution of products.

We have independent Corporate Quality Assurance Department responsible for quality affairs.

We believe to deliver the highest level of quality and customer satisfaction. ISO 13485:2016 Certification for Quality Management from UKAF and WHO-GMP from UKC&IL.

Accreditation explains our efforts to achieve maximum quality level. Quality Assurance is a measure of the degree of sophistication of managerial, scientific, and technical tools used in the plan and execution of production processes of any industry. In the pharmaceutical industry, QUALITY is the most fundamental task of Total Quality Management. We at Medec are committed to ensuring that every product we manufacture and distribute meets with and conforms over its shelf life to internationally accepted standards of quality, purity, efficacy, and safety. Medec quality focus encompasses all areas of operation – from procurement of the best raw materials to optimum manufacturing technology, to the precise delivery of the customer’s requirements – thus ensuring rapid access of both domestic and global markets. All our systems are well documented and are implemented by an expertly trained staff with a line of reporting that is independent of manufacturing.

We have state of an art laboratory with advanced infrastructure and procedures to support a stringent quality policy. At our manufacturing site, the latest analytical instruments and firmly monitored quality assurance and quality control systems ensure the consistent quality of our products. There is regular validation of processes, test methods, water, and environment, as well as periodic calibration of all instruments, to guarantee product output of consistent top quality. Vendor evaluation and selection are carried out as per stringent quality, product, manufacturing, service, and delivery parameters to ensure the highest quality raw materials. The Quality Assurance Department accomplished by qualified personnel, constantly monitors quality parameters and performs systematic sampling and testing at every stage from raw materials, through each process of intermediate and finished products. A full-fledged Quality Control Laboratory which follows Good Laboratory Practices and incorporates the most modern testing equipment, in order to perform the stringent quality analytical tests prescribed by different national and International Pharmacopoeia

We promised to take care… and delivered