Regulatory Support Services

Understanding our clients’ regulatory requirements, technical and commercial expectations is key to our business

Comprehensive Regulatory Services

Within the framework of an API project, LGM Pharma can provide comprehensive regulatory services,
including:

  • Elaboration and evaluation of Active Substance and US-Drug Master Files (ASMF & DMF),
  • Quality Overall Summary (QOS) and Certificates of Suitability (CEP)
  • Escort of registration procedures (MRP, DCP)
  • Independent GMP audit reports
  • Regulatory strategy development and implementation
  • Regulatory submission oversight, management, preparation, maintenance, and quality assurance
  • Regulatory authority interactions, including serving as US Agent
  • Regulatory compliance gap analysis and issue resolution
  • Scientific, regulatory, and due diligence reviews of regulatory documents and submissions
  • Regulatory and scientific document development, preparation, and quality assurance

Patent Investigations

  • Evaluation of possible patent infringements supported by 3rd party patent lawyers
  • Issuance of Freedom to Operate (FTO) legal opinions towards Paragraph IV filings

Neutral GMP Audit Reports

  • Reliable factory
    inspections by means of 3rd party audits conducted by
    independent audit
    teams

Analytical Support

  • Structure Elucidation
  • Method development and transfer

Reference Substances

  • Supply of reference standards and
    related compounds that may be
    unavailable from the listed pharma copeias

Polymorphic Studies

  • Identification of polymorphic forms
  • Evaluation towards patented polmorphs