Simplifying Regulatory Affairs from Product Development to Commercialization
The Regulatory affairs function in the pharmaceutical industry has a huge responsibility to ensure that new medicinal products are developed, manufactured, and marketed in compliance with global and regional regulatory requirements.
In recent times, Pharma companies and Life Sciences organizations are challenged with an increasingly complex regulatory landscape that has evolved dramatically to ensure better public health with a laser focus on patient safety, product efficacy, quality, risk management, transparency, and compliance.
Our Global network of Regulatory Center of Excellence will provide the services for all major markets such as – North America, Europe, Middle East, LATAM, Africa and Asia Pacific. Techsol’s Service Delivery Centers are located in US, South Korea, EU and India.
Our Capabilities
With over 15+ years experience, our regulatory professionals have helped several pharma and medical device companies by delivering clinical, non-clinical, and post-marketing related regulatory services.
Following are some of the key areas of where we provide specialized regulatory knowledge and operations support.
Submission Preparation
Assist with the preparation of regulatory submissions, including new drug applications (NDAs), investigational new drug (IND) applications, and marketing authorization applications (MAAs).
Regulatory Strategy
Support sponsors to develop and implement regulatory strategies, including identifying and addressing regulatory risks, determining the optimal regulatory pathways for approval.
Regulatory Intelligence
Provide regulatory intelligence and guidance on emerging regulations, changes to the regulatory landscape, and the latest regulatory trends for drugs, biologics and medical devices.
Regulatory Operations
Manage the day-to-day operations of the regulatory function, including document management, submission tracking, and interactions with regulatory agencies.
Post-Approval Support
Support ongoing regulatory needs after a product has been approved, including ongoing regulatory compliance, label updates, and periodic reporting requirements related to product safety.
Global Regulatory Affairs
Offer global regulatory consulting expertise in specific regions and therapeutic areas, as well as support for cross-border regulatory submissions and Health Authority interactions.
Our Regulatory Affairs Services
At Techsol, our expert team of Regulatory Affairs professionals have extensive expertience to support end-to-end sevices throughout the product lifecycle of drugs, medical devices, and other healthcare products.
We provide the following services focused on supporting companies as they advance their drug, biologic, device, and/or combination products through regulated pathways from development to commercialization.
