Your guide in documentation

Regulatory compliance requires vigilance. Lannett offers end-to-end support to help simplify this process for a smoother route towards approval.

Your guide in documentation

Experts in their scope, our dedicated team can be consulted to confer clarity and filing strategies at any step. We provide pharma regulatory support that can guide you through every stage of the process, ensuring compliance with FDA regulations and requirements. We do things at Lannett with heart and commitment, including regulatory support.

Our assistance can include:

CMC Guidance
CMC Guidance
505(b)(s) Guidance
505(b)(s) Guidance
Planning/preparation of regulatory documentation
Planning/preparation of regulatory documentation
Post-Approval product management
Post-Approval product management

Get help with regulatory compliance

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