Regulatory Affairs

DOSSIER & VARIATION SUBMISSIONS:

Regulatory submissions are the cornerstone of product approval and maintenance. Altiveno provides expert support in preparing, reviewing, and submitting dossiers and variations that meet the highest global standards.

Our team ensures that every submission is complete, accurate, and strategically positioned to minimize delays and maximize approval success. From initial filings to post-approval variations, we manage the process end-to-end, giving you peace of mind that your regulatory documentation is in safe hands.

CHEMISTRY, MANUFACTURING & CONTROLS:

The CMC section of regulatory submissions is often the most complex—and the most scrutinized. Altiveno brings deep expertise in Chemistry, Manufacturing & Controls, ensuring that your product’s quality, safety, and consistency are clearly demonstrated to regulators.

We work closely with your technical and manufacturing teams to compile robust CMC data packages, align with regulatory expectations, and anticipate potential challenges. With Altiveno, your CMC documentation becomes a strength, not a stumbling block, paving the way for smoother approvals and long-term compliance.

LIFE CYCLE MANAGEMENT (LCM):

Regulatory compliance doesn’t end at product launch—it evolves throughout the product’s life. Altiveno provides comprehensive Life Cycle Management support, helping you maintain compliance, manage variations, and respond to regulatory changes across global markets.

We ensure that your products remain aligned with evolving requirements, from safety updates and labeling changes to manufacturing modifications. With Altiveno’s LCM expertise, you can focus on growth and innovation while we safeguard your regulatory standing.