LGM pharma’s unique mix of API sourcing and CDMO services is fueling robust growth

Regulatory Support

Get API Regulatory Support for the Pharmaceutical Industry

Support for on-time development of programs and compliance with local and international regulatory requirements

It can be incredibly challenging to stay current in the complex, highly regulated pharmaceutical market, given ongoing regulatory changes and the potential for global supply instability. Let LGM Pharma’s regulatory team manage all regulatory submissions for API procurement or development and finished product so you can focus on your mission – getting your drug to market. Our drug substance team has decades of global regulatory experience in the pharmaceutical industry and interaction with the FDA; as your strategic partner, we manage the nuances of today’s regulation, ensuring both compliance and on-time submission.

How We Work

Our Quality and Regulatory Team is your advocate not only with the API manufacturer but also with the relevant regulatory body. We ensure all product-specific regulatory and quality data and documentation is assembled and in order – giving your API a smooth global journey from manufacturer through delivery at your doorstep. Our validated ERP system enables a continuous focus on CFR Part 11 and data integrity compliance. And, a tight integration with LGM Pharma Sourcing and Logistics teams ensures compliance through the entire chain of custody.

LGM Regulatory Support Services

  • Evaluation of active substance and technical writing and compilation of US-Drug Master Files
  • Expert regulatory CMC compliance guidance throughout development
  • Writing and assessment of quality/CMC regulatory document (Module 2 and 3)
  • Coordination with clinical trial partners to ensure eCTD compliance (Module 5)
  • Critical writing and review of drug substance and drug product documentation
  •  Adherence to CFR regulations and guidance documents to ensure timely approval of new ANDAs, amendments, and post-approval changes
  • Expedient response to IRs and CR prior to due date
  • 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

With decades of global regulatory experience in the pharmaceutical industry, LGM Pharma works as your strategic partner to manage the nuances of today’s regulation – ensuring both compliance and on-time submission.