Regulatory Affairs consultation & strategy development

Over the course of years, our team of experts has connected the missing link between organization and global Health Authorities. We track all the key regulations issued by authorities related to products. PRA has the knowledge & market experience of getting you the approvals. Strategic inputs get provided from the start through our consultation; segmentation/niche indications, conditional approval/fast track.We provide you with an oversight on all regulatory requirements to access the target market.

Roadmaps for Regulatory Strategy

A complex and costly process like drug development necessitates a clear and consistent strategy from which to design and implement a tactical action plan. This regulatory roadmap lays out significant development milestones and success criteria, makes cost and timetable estimations easier, and serves as a foundation for smart decision-making, portfolio prioritization and management. Our roadmap is prepared by a team of multidisciplinary experts and is a living document that gets updated on a regular basis to include alternate development possibilities or scenarios. This will help prevent or lessen hazardsor give hands-on operational support by authoring some or all of the components.

Get Regulatory Expertise Through PRA Consultancy

  • MAH and Manufacturer Registration
  • Product Classification and Registration
  • Product Lifecycle Management (variations and renewal)
  • Importation Permits
  • Label Validation and Modification
  • Dossier Preparation (CTD & e-CTD)
  • Medical Translation (labels and artwork and PIL)
  • Marketing and Advertising Approval
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