Strategic, Timely, Accurate, Regulatory Services To Every Client






Our Services - Small Molecules

We provide support for Active Pharmaceutical Ingredients and Finished drug products; original, generic and orphan drugs.

Regulatory procedures

  • National, MRP, DCP, CP, DMF, NDA, JNDA etc.

Countries in scope

  • worldwide

Regulatory CMC, pre-clinical and clinical support during development and lifecycle management

  • Regulatory strategy
  • Scientific advice meetings with Health Authorities
  • Dossier Due Diligence
  • Dossier maintenance / Lifecycle management
  • Authoring of CTD Modules and other required documents
  • Preparation and gathering of ancillary documents
  • Response to questions from Health Authorities
  • Labelling support and safety variations
  • Clinical trial applications, new submissions, variations, renewals and annual reports
  • Gap analysis and remediation packages for compliance activities and regulatory submissions

Areas of regulatory expertise

  • Different formulation types: solid dosage forms, injections, special dosage forms
  • Development of drugs:

    o New APIs / NCEs

    o New formulations / reformulations

  • Process validation
  • Stability testing
  • Changes in source of supply and changes in ownership for API, finished dosage forms, excipients and packaging operations
  • Other post-approval changes, e.g. changes in:

    o Manufacturing process

    o Composition

    o Analytical method and/or specification

    o Container closure system

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