Regulatory Lifecycle Management
Pharma companies and Medical Device manufacturers need a highly competent Regulatory Affairs and Medical Writing team to fulfill regulatory compliance obligations at every stage of the medical device product lifecycle. From pre-market submissions to post-market surveillance, it is critical to ensure that all quality, risk and compliance management processes are tightly integrated into the regulatory strategy.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
How We Can Help
Following are the areas where we support pharmaceutical sponsors and medical device companies to establish a comprehensive Regulatory Lifecycle Management process.
Your Questions & Our Answers
At Techsol, we have developed a culture that embraces a continuous growth mindset which is fostered by incremental innovation. As a leading solutions provider, we have partnered with the best of technology providers to deliver their innovative products to our clients.
Additionally, we have developed our own proprietary platforms which we provide using the SaaS model. Our SciMax Platform for Medical Affairs and the COMPIER platform for GxP Operations Oversight have led us to the forefront as emerging market leaders in delivering tech innovation.
We always strive towards delivering products and services with the highest quality by adhering to best practices, global standards and applicable regulations.
As an organization, we have ISO 9001:2015, ISO 27001, ISO 14155:2011 and ISO 13485:2016 certifications to account for GxP Quality and Compliance.