HPC offers regulatory affairs services with a framework of structured phase-appropriate frameworks in line with FDA, EMA, and ICH. It starts with an in-depth analysis of the regulatory environment to establish classification, pathway, and submission strategy (IND, NDA, DMF, CTA, or regional counterparts). Gap analysis of the preclinical, CMC and clinical data is conducted in detail to determine the deficiencies and areas of risk. According to this evaluation, HPC prepares an individual regulatory plan and roadmap of submission.

The document preparation is done in a modular manner (CTD/eCTD format) which involves authoring, technical revision, quality inspection and alignment across functions. HPC additionally prepares regulatory briefing packages, arranges scientific advice meetings, and prepares structured responses to agency queries. Lifecycle management involves amendments, variations and post approval changes which are planned and implemented. Risk mitigation, timeline tracking and regulatory intelligence updates are also used throughout the process to ensure submissions are compliant, consistent and placed in a position that is easy to review by the health authorities.