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:
- Ensuring accuracy and completeness of information
- Drafting content as per latest regulatory guidelines
- Effectively communicating complex information
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
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.
Regulatory Intelligence & Strategy Planning
We help sponsors to stay up-to-date on changes in regulations and industry standards by providing them with access to a database of current and historical regulatory information, as well as tools for tracking and analyzing regulatory changes.
Regulatory Documentation Management
Manage their regulatory documents and submissions, including creating and updating regulatory dossiers, tracking submission status, and maintaining records of submissions and approvals.
Regulatory Reporting & Health Authority Interactions
Prepare and submit regulatory reports and returns, including annual and periodic reports, and returns required by regulatory authorities.
Regulatory Training and Awareness
Deliver training and awareness programs to ensure that sponsor teams are knowledgeable about regulatory requirements and understand their role in ensuring compliance.
Regulatory Compliance Monitoring
Monitor and maintain compliance with regulations by providing them with regular compliance assessments and recommendations for improvement.
Regulatory Technology Solutions
Implement modern technology solutions to support their RIM processes, such as regulatory information management software, document management systems, and compliance management platforms.
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.