Medical device, pharmaceutical and biotechnology/biopharmaceutical companies are regulated by the FDA and other global, regulatory, bodies. Regulations aim to ensure that products are deemed relatively safe and effective throughout their total product life cycle. Each phase of product pipeline requires appropriate planning, implementation and testing to ensure regulatory compliance, remove risk from the development process and get products to market in a timely manner.
Regulations are complicated and requirements may change. Navigating product development – from R&D to CQV – will make the difference in financial performance and speed to market.
Apex helps clients implement or remediate processes, systems or key components of their Quality Management System (QMS) while focusing on industry alignment, quality, and productivity.
Implement sustainable, maintainable and compliant solutions, develop fully validated production processes and ensure adherence to the requisite FDA regulations, International standards and company requirements.