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.
Our aim is to build a team of motivated staff with world class competencies and offering
continuous trainings to increase their skills, benefiting both associates and Organization.
Our philosophy is to create systems that are simple and based on good science and are in
compliance with Global regulatory requirements.
Regulatory
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.
