Regulatory compliance requires vigilance. Lannett offers end-to-end support to help simplify this process for a smoother route towards approval.
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 Guidance505(b)(s) GuidancePlanning/preparation of regulatory documentationPost-Approval product management
