Quality Assurance

Rakshit is committed to maintain best Quality Standards in Research and Manufacturing of Pharmaceutical products through periodic reviews and continual improvement of Quality Management System, and strive to enhance customer satisfaction.

RAKSHIT STANDS FOR ASSURED QUALITY
  • Our mission in Quality System is committing to strict compliance of cGMP and make sure continuous improvement of Quality & in time deliveries.
  • Facilities are certified by USFDA, EDQM, EU GMP, TGA, ANVISA, COFEPRIS, Japan PMDA, Korea MFDS, CDSCO-India and WHO-GMP
  • Stringent Quality checks and procedures in place at all levels of API manufacturing from raw materials sourcing to sales and after sales service.
  • The main objective for quality assurance and technical team of Rakshit is to carry out continual development of its processes, procedures, people and products.
  • Rakshit objectively works on In-process control, prevention of contamination, change control system, complaint, Recalls /rejections, System for controlling complaints and rejection and Regulatory support to customers.
Quality image
Regulatory
Regulatory Image

Rakshit is fully committed to ensuring our manufacturing facilities comply with international regulations for current Good Manufacturing Practice (cGMP); GLP and all locally applicable regulatory requirements.

We have been exporting to over 80 countries, with our facilities having been audited by Global Regulatory agencies like the USFDA, EDQM, EU GMP, TGA Australia, ANVISA Brazil, COFEPRIS, Japan PMDA, Korea FDA, CDSCO-India and WHO-GMP

  • With over two decades of experience working with regulated market partners, we understand the need of our customers. Hence, we offer regulatory support in addition to compliance with the regulatory requirements of various agencies.
  • Our firm has a very collaborative, knowledge-sharing, and assimilating culture in Regulatory Affairs domain.
  • Rakshit Processes are monitored to guarantee the desired Quality, as per the current Regulatory trends.
  • We are a strategic partner across the product life cycle and responsible for quick approvals of filings made by Global clients.