Search Results for: FDA

Leachables & Extractables We provide leachables and extractables (E&L) services based on risk-based, lifecycle-integrated approach. The process starts with a review of the material and system characterization, such as packaging components, container-closure systems, processing equipment, and product-contact materials. The risk assessment is performed in a structured way to determine the possible sources of extractables, depending

Regulatory Affairs 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

Meet amazing people behind our support We have highly trained staff with International and National Experience Dr Umar Hayat CEO / Founder Dr Umar Hayat CEO / Founder Umar Hayat, Ph.D. is a founder of Trials 360 and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior

Meet amazing people behind our support We are a dynamic team of pharmaceutical development experts and regulatory strategists. HPC is a global team of technical experts and regulatory experts who provide end-to-end drug development solutions to our clients, including early research and commercial launch. Our expertise enables clients to navigate complexity, conquer scientific challenges, and

Solutions for a Healthier Tomorrow Explore expert-led pharmaceutical and consulting solutions. Strengthen your development and regulatory journey with us. Collaborations 0 + Projects 0 + Projects in Pipeline 0 + From Scientific Discovery to Safe & Effective TherapiesQuality, Compliance, and Confidence at Every StepBusiness Impact Through Strategic Collaboration Why Clients Trust HPC Industry-Focused Expertise We