Protect your drug product with knowledgeable regulatory management services that lead, as smoothly as possible, to FDA approval, and maintains regulatory compliance throughout the product lifecycle.
LGM Pharma’s dedicated expert regulatory services team – embedded in our R&D department – knows how to compile and maintain new drug applications (NDA), abbreviated new drug applications (ANDA), and other regulatory pathways such as 505(b)(2), for a successful FDA review. With two DEA-licensed facilities, we also handle Class II-V controlled substances.
We develop efficient regulatory strategies and pathways that lead to approval.
Our proprietary process integrating Product Development and Regulatory resulted in 4 regulatory approvals and 3 successful commercial launches in a recent 12-month period.
For confidence in your regulatory strategy, pathway, and submissions, rely on the knowledgeable, dedicated services from LGM Pharma’s regulatory management team. Our unique integration with product development and attention to detail yield a thorough filing submission that reduces regulator questions and delays.