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Global Regulatory Solutions — old

Your Trusted Partner for Navigating Compliance

For pharmaceutical and biotechnology industries, where regulation is stringent, a well-crafted regulatory strategy is vital for successful market introduction and managing global market intricacies. Our comprehensive service portfolio offers insights and solutions necessary to meet global regulatory requirements, boost compliance, and ensure successful product approvals.

Clinical Trials Regulatory Affairs

  • Regulatory Pathway Strategy
  • CT Application Submission (India, USA)
  • EU CTR/CTIS Submission (EU)
  • RPEV Representation
  • IND eCTD publishing
  • IND Gap Analysis & eCTD conversion

Regulatory Affairs

  • Dossier Compilation
  • Post-Approval Changes (CBEs or Variations)
  • Product Life Cycle Management
  • Transfer of Applications (Change of Ownership)
  • DMF Transfer
  • Regulatory Publishing
  • Regulatory Submission

Regulatory Writing

  • Clinical & Non-Clinical Overviews (2.4 & 2.5) & Summaries
  • Support of Integrated Summaries
  • Annual Reports (for USFDA)
  • Response document to Regulatory Queries
  • Clinical Expert Statement (eCTD 1.4.3)
  • Specialized Regulatory Solutions

SME Regulatory Service

  • US Agent Nomination & Deputation
  • Eu/Non-EU QPPV Services
  • Impurities Assessment
  • Regulatory FTEs (Resource Provision)

Regulatory PV

  • Summary of PV System (eCTD 1.8.1), PSMF
  • Risk Management Plan (eCTD 1.8.2)
  • Pre-Authorization Literature
  • xEVMPD/IDMP

Medical & Scientific Communication

  • Promotional & Non-promotional Content creation
  • Content Management
  • Sales Reps training Documents

Labelling & Artwork Management

  • Drafting SmPC, PILs, PIs, Medication Guide
  • Investigational Brochures (IB)
  • Developmental Core Safety Information/CCSI
  • Company Core Data Sheet

Request for Proposal

Ready to streamline your regulatory journey? Get in touch with us today to learn more about how we can support you in adhering to compliance.