Strategic Consulting
DataRevive’s strategic consulting services begin with regulatory pathway guidance, and we have specialized expertise in regulatory strategies for breakthrough and fast track approvals, accelerated approval, and orphan drug applications. From there we support strategy and planning for CMC, preclinical, and clinical study design through to pre-registration, registration, and post-approval management.
Throughout these processes, we help continually refine your regulatory strategy and documentation in line with product development realities as well as evolving regulatory guidance.
Execution Services
Our lead consultants actively participate in and oversee execution of defined strategies from dossier writing, filing, and maintenance for INDs, BLAs, and NDAs to pre-approval mock inspections. We will also represent you at health agency meetings as an expert voice with an insider’s understanding of their regulatory processes and requirements.
Ongoing Support
DataRevive is your one-stop-shop for regulatory strategy, but we also extend support post-approval with services such as GMP mock inspections and regulatory agent services. As a Validant company, we are part of a team specializing in every facet of the GxP product lifecycle.
