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 professional regulatory team is well-versed in FDA regulations and remains vigilant in tracking ever-changing guidances and requirements. With R&D backgrounds, they’ve been doing work in submissions, filings, registrations, licensing, and labeling for well over two decades, and bring pharmaceutical industry experience to LGM Pharma.
Knowing what the FDA expects, LGM Pharma’s regulatory professionals prepare and document the most comprehensive story about your drug product’s development, processes, and data to support approval. This reduces the back and forth with regulators that can often lead to delays.
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.
LGM PHARMA
Call Toll-Free: 1-800-881-8210
Corporate Headquarters:
6400 Congress Avenue, Suite 1400
Boca Raton, FL 33487, USA
