Regulatory Affairs

Overview

Drug development to commercialization involves many steps which are completely governed and regulated by global Health Authorities. Ensuring compliance throughout the process is a mandatory requirement and to overlook the procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs. The expert team in fact acts as a crucial link between organization and global Health Authorities, tracking all the key regulations related to the product and prerequisites for its launch. In the current situation, not many organizations have the privilege to have these teams in-house given their dedicated focus and approach towards innovation and drug safety.

At times, as a specialized global Regulatory Affairs partner, Reg Solutions acts as a bridge between organizations and key regulators like, the US FDA, Health Canada, and the European Health Authorities. Reg Solutions is a leading Regulatory affairs services company and has been a pioneer in providing strategic multidisciplinary Regulatory affairs consulting services worldwide. Reg Solutions provides comprehensive Regulatory affairs services across the spectrum of product development, registration and commercialization.

Reg Solutions global Regulatory affairs services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize their market value.

REG Solutions Expertise

• Submission Forecast and Planning

• Submission Document Management and Tracking

• Regulatory Content Management

• Change Control Management

• Label Change Tracking

• Integrated Regulatory Information

• Regulatory Intelligence

• Reporting and Analytics