We provide complete solution and service for managing the Quality Management and Regulatory Compliance for Medical Device, Biotech and Pharma Companies.
This includes QMS set up, maintainance and improvement. We also provide Regulatory compliance management services including 510K filing, IND, ANDA, DMF filing and others.
Followings are key features and capabilities of our QA/RC consulting service options.
More about our QA/RC Consulting Solutions
We have team of experts who are available for helping our customers. Our services combined with software platform, enables our customers scale up opearations and launch products faster to market. We support our customers end-to-end so that they can go to market faster with a small team. We help reduce the risk involved in the new product launches.
Highlights of the Features and Options
Our consultants help our customers estblish QMS systems from scatch. We provide training services to enable our customerunderstand the functionalities of the QMS and be capable of running the QA/RC function independently.
The followings are highlights of our eQMS platform:
There are other systems available in the market which are not flexible or user friendly. We have developed a system that is easy to implement and easy to use. The system has built in features that enable compliance with regulatory requirements such as ISO 9000, 21CFR Part820, 21CFR part 211.