Regulatory Affairs

As an established Regulatory Consultancy and Service Provider, ELC has key experts who are prominent in the Regulatory Affairs sector ensuring clients are always kept up to date. Along with it, ELC's consultants have an extensive knowledge and experience in all aspects of regulatory affairs across various industry disciplines and a wide range of product profiles.

Clinical Trials

Pharmaceutical Registration

We can provide selected resources and support as you undertake procedures, or manage the entire cycle from the compilation of application forms through to obtaining marketing authorization.

  • Analytical Testing
  • Batch Release Site
  • eCTD Creation
  • Dossier Review
  • Pricing & Reimbursement

EU GMP Audit (linked to GMP Audit)

Readability Testing

  • Readability testing
  • Bridging statements
  • Bridging Reports
  • Format Bridge
  • Double Bridging Reports
  • Focus Tests
  • Format Focus Tests
  • Mock-ups
  • Mutual Testing
  • Mutual Bridging Studies


Market Access

  • Distributor Search
  • Local Company Representative
  • Company Registration