Regulatory Management

Enhance Your Strategy with LGM Pharma Regulatory Management Services (CMC)

Rely on expert regulatory support for successful FDA submissions and ongoing compliance

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.

Regulatory Team Expertise

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.

Integrated with Product Development

Our proprietary approach to integrating our product development and regulatory teams provides the framework for successful projects. LGM’s stage gate system, in which information and documentation is shared in real-time across both teams, offers a detailed roadmap for success – from project initiation to post-approval commercial manufacturing.
Process for Integrated Product Development and Regulatory Submissions

Our proprietary process integrating Product Development and Regulatory resulted in 4 regulatory approvals and 3 successful commercial launches in a recent 12-month period.

Regulatory Services Offered

  • Application preparation, compilation, and submission – for the regulatory pathway best suited for your needs; includes CMC drafting, PAS and CBE filings in e-CTD format
  • Support throughout the regulatory engagement – including communications with regulators
  • Filing maintenance and lifecycle support – to ensure your filing is compliant post-approval

True Regulatory Management

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.