Regulatory Affairs
consulting solution

In the ever-changing pharmaceutical regulatory environment, it is important for pharmaceutical companies to keep their knowledge abreast of international legislations, guidelines and customer practices in all countries.

Regulatory affairs
consulting
& strategies

Our Regulatory Affairs Service at Glance

  • Advice on Regulatory strategies for successful product market entries across the globe
  • Guidance for regulatory pathway that is necessary for timely regulatory approval
  • Advice on industry trends and current market needs
  • Advice on Regulatory Affairs and Regulatory Operations Outsourcing
  • Advice on the Regulatory mergers and acquisitions
  • Regulatory classification of products across different jurisdictions
  • Conduct face-to-face Meetings with Regulatory Authorities
  • Provide expert regulatory CMC compliance advice throughout development

Regulatory Affairs Services

Regulatory Affairs
Predefined support
  • FDA registration and labeler code
  • US FDA Agent Service
  • FDA Registration Renewal
  • FDA Food Facility Registration
Regulatory Affairs
On-going support
  • eCTD Publishing and Validation
  • Dossier development and submission
  • Premarket Notification(510k)
  • Medical Device Establishment Registration & Listing with US FDA
  • Structured Product Labeling for Establishment and Product
Adhoc Support
  • Registration of Food facilities
  • Dietary supplement –
    Review the product Labeling
  • Food Supplement – Prior Notice
  • Voluntary Cosmetic Registration Program
  • Cosmetic Labeling Review
  • FDA Unique Device Identifier

Fields of expertise

Lifecycle Management/
Post Approval Activities

Regulatory Consultation

Market Access and Regulatory Strategy

Publishing and Submissions

Regulatory Labeling

Regulatory Artwork Services

Regulatory Medical Writing

Health Authority Interaction

Product Registrations and Market Authorizations

We work in strict adherence to the applicable regulations and guidance by the authority. Our SOPs and Work Instructions are based on Regulations, Guidance and Industry Best Practices.