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.
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 PHARMA
Call Toll-Free: 1-800-881-8210
Corporate Headquarters:
6400 Congress Avenue, Suite 1400
Boca Raton, FL 33487, USA
