Establishing a regulatory roadmap for post-approval lifecycle management

A drug product transitions from different phases throughout its life cycle. The sponsors/applicants may outsource the management of post-approval life cycle to the regulatory service providers and leverage their regulatory knowledge and expertise in creating high quality dossier packages with quick turnaround and in a cost-effective manner.

Learn how APCER’s regulatory team supported one of the global Biopharma company in timely submitting eCTD dossiers in different geographies, managed hassle-free transition of data from other service provider and also ensured close monitoring and compliance to regulatory commitments.