Regulatory
Procept Partners provide comprehensive regulatory services designed to navigate the complexities of the pharmaceutical and medical device industries. Our team of experts specializes in developing and implementing regulatory strategies that meet global standards, including FDA, EMA, and other international health authorities.
We have experience in the full life cycle for submissions and post approval management for IND, IDE, NDA, BLA, PMA, and 510(k) applications.
Our services include submission authoring, expert review, data/documentation mangement, submission and and engagement with health authorities.
Quality Systems
Procept Partners excels in providing robust quality systems services tailored to the pharmaceutical and medical device industries. Our expertise encompasses the development and implementation of GMP and GCP quality management systems that ensure compliance with regulatory standards and support business objectives.
We assist clients in creating, auditing, and improving quality processes, including design controls, risk management, supplier controls, and clinical operations.
Our team specializes in quality system integration, particularly during mergers and acquisitions, and offers remediation support to address compliance gaps identified during inspections.
With Procept Partners, you gain a partner dedicated to elevating your quality systems to the highest standards of excellence.
Product Development
Our Lead CMC R&D Development Services focus on the scientific management of product development and process transfers. We collaborate with third-party service providers and suppliers to ensure the highest standards of quality and efficiency.
Our team expertly manages the critical aspects of Chemistry, Manufacturing, and Controls (CMC), facilitating smooth transitions from development to production. We provide comprehensive data management solutions that ensure the integrity and reliability of information needed for regulatory submissions, supporting successful product approvals and compliance with industry standards.
Project Management
Our project management services ensure timely, within-budget delivery of pharmaceutical and medical device projects. We excel in comprehensive planning, resource allocation, risk and budget management, quality assurance, and stakeholder communication. Our experienced project managers utilize industry-leading tools to monitor performance, maintain compliance, and ensure successful regulatory submissions, providing clients with confidence and support to achieve their goals.