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Global Regulatory Solutions

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.

  • Experince in Range of Products Medicine- Generic/Branded, Biologics, Combination Products, class I device)
  • In-House Team of Regulatory Experts and International Regulatory Contact Points
  • Associated with different clients across EU & USA Regions
  • Inhouse eCTD & SAS

Proven Track Record: Our Regulatory Expertise

280 +

MA Transfer Support

88

Annual Reports

430 +

eCTD Publishing

59

Safety Labelling Changes

3896

xEVMPD entries

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

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.