How can you ensure that a completed project fully complies with GMP and URS (User Requirement Specification) standards? How can you enhance your quality system in pharmaceutical production? How can you prepare your company for an official inspection by regulatory authorities?
Our GxP quality and standards team is ready to provide expert solutions in pharmaceutical engineering, compliance, and quality assurance, addressing these and other critical questions.
Our services include:
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Expert review (DQ) of project documentation (conceptual design, design stage, working documentation) for compliance with GMP and URS requirements.
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Quality audits according to GMP, GDP, and GLP standards.
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Assessment of the existing quality system with actionable recommendations for improvement.
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Assistance in developing User Requirement Specifications (URS) and design briefs.
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Consulting in validation and qualification, including development of validation master plans (VMP) and review of validation documentation.
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We follow current GMP EU requirements, ISPE, PDA, WHO, and other regulatory guidelines.
Our specialists have experience in conducting GMP inspections/audits as per requirements from foreign pharmaceutical manufacturers, performing expert assessments of project documentation, and managing quality throughout the entire project lifecycle.