Regulatory Affairs

  • Home
  • Regulatory Affairs

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 pre-requisites 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, Intellectt acts as a bridge between organizations and key regulators like, the US FDA, Health Canada, and the European Health Authorities. Intellectt is a leading Regulatory affairs services company and has been a pioneer in providing strategic multidisciplinary Regulatory affairs consulting services worldwide. Intellectt provides comprehensive Regulatory affairs services across the spectrum of product development, registration and commercialization.

Intellectt’s 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.

  • FDA Regulatory Compliance Strategy
  • Premarketing Clearance 510(k) Submissions
  • Device Classifications and Product Listings
  • 510(k) Exemptions
  • FDA Biocompatibility Requirements
  • Mock FDA Audits
  • Warning letter (Form 483) Responses & Activities
  • International Import/Export Issues
  • Regulations for packaging and labeling