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Process Validation

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols incorporating all critical parameters of the process. Execution will incorporate data analysis and resolve any non-conformances. PharmEng will collect and evaluate data to ensure that a process is capable of consistently operating according to determined standards. Our professionals provide effective process validation which contributes significantly to assuring drug quality.

Our project execution will include evaluating the process capability of the manufacturing and testing procedures using statistical techniques. By teaming up with the R&D, Operations, Quality Assurance, Regulatory Affairs personnel, PharmEng will ensure that all regulatory requirements and specifications are met.

Our project management skills will ensure that all documentation, written and provided, will meet the standards of international regulators and the Quality Assurance team. Our team's results and deliverables are well accepted by FDA and Health Canada regulatory bodies. PharmEng will provide your company with results that exceed your expectations.