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