Our Commissioning & Qualification services ensure that your facility and equipment function effectively and meet regulatory requirements. We provide comprehensive support throughout the process, from User Requirement Specification to Risk Assessment and Validation Master Plan.

Our team can assist you in deciding on the most suitable qualification strategy for your equipment and facilities. We cover a wide range of utilities, systems, and equipment, including air treatment systems, clean rooms, utilities, thermal equipment, and production equipment.

Promeridian offers Process Validation services, employing a life cycle approach and a risk-based control strategy to effectively manage variability and maintain control. We cover aspects such as Continued Process Verification, cleaning validation, and clean and dirty holding time.

We ensure compliance with GxP regulations, Annex 11, and 21 CFR Part 11 by validating computerized systems used in manufacturing, warehouse, distribution, and quality control processes. Our services cover all stages of the system life cycle, including planning, specification, configuration, verification, and reporting. Additionally, we provide support for system inventory, Validation Master Plan, IT infrastructure qualification, periodic review, retirement, and decommissioning.

We offer expertise in drug formulation and reformulation for all forms of drugs, including chemicals and biosimilars. Our focus is on the development of value-added generic drugs and complex formulations to ensure optimal technology and profitability for our clients. We also assist in prospecting for acquisition of drug files and technology transfer.

Our experienced team develops, validates, and transfers analytical methodologies essential to pharmaceutical development programs. We specialize in creating precise methods for low Limit of Qualification (LOQ) levels, supported by our in-house scientific experts who help interpret test data and address potential issues, including deviation analysis.

Promeridian's experts continuously optimize processes to ensure uninterrupted market supply. We combine innovative and well-established technologies with intelligent solutions to prevent downtime, increase production yields, and reduce defects, ultimately helping you achieve your goals and minimize costs.