Our Regulatory Affairs Expert Team

  • Accumulated extensive 20-year experience in dealing with research oriented pharmaceutical companies
  • Provided regulatory consulting and product registration services for
    • New biotechnology,
    • Generic Drugs,
    • Health Supplement,
    • Cosmetic Skincare,
    • Medical Devices Product

Reasons for the Best Regulatory Intelligences

  • A good regulatory profession is the crucial link to bring good success to company.
    • The company and products can be fatal if even a small mistake in any of the activities related to regulatory 
  • Outsourcing to external regulatory provider can be cost-effective
    • Excessively heavy workload in the company’s regulatory affairs.
    • Project-based relationship and no entitle of company benefits.
  • Regulatory Affairs Professionals are in high demand in view of massive new initiatives in compliance from Authorities,

Pharmaceutical Regulatory Affairs Services

  • Development of regulatory strategy for the product’s life cycle
  • Dossier review/submission preparation and filing
  • Liaison with regulatory authorities & communicate with the Authorities on your behalf
  • Registration renewals and post-market compliance
  • Labelling requirement assessments
  • Marketing Authorization Holding and maintenance
  • Life cycle management of recently marketed & older products
  • Labeling Updates and Harmonization of Labels
  • Products or Licenses Transfers
  • Product Acquisitions (regulatory due diligence)
  • Advertising and promotional materials compliance check
  • Regulatory certificate applications (clinical import, Secondary Packaging, wholesales dealer…)
Regulatory Affair Consultancy Service