At Stark Pharma, we provide comprehensive validation services that align with global regulatory requirements including FDA, EMA, MHRA, WHO, and CDSCO. Our focus is on quality, data integrity, and risk-based approaches to ensure that your systems, processes, and equipment are fully compliant and ready for inspection—every time.
We offer full lifecycle validation of computerized systems used in GxP environments, following GAMP 5, 21 CFR Part 11, EU Annex 11, and applicable data integrity guidelines. Our services include validation planning, system assessments, IQ/OQ/PQ execution, and audit readiness for systems such as QMS, LIMS, ERP, and clinical software.
Our qualification services cover manufacturing equipment, utilities, cleanrooms, HVAC, analytical instruments, and more. We support protocol generation (URS, DQ, IQ, OQ, PQ), execution, documentation, and deviation handling, ensuring regulatory compliance and continuous operation.
We design and execute validation studies for pharmaceutical and medical device manufacturing processes, as well as cleaning protocols. Our team ensures robustness, repeatability, and alignment with ICH Q8/Q9/Q10 guidelines.
We support validation of EtO, moist heat, and gamma sterilization processes along with packaging validation including integrity testing, transport simulation, and shelf-life studies—especially critical for our own medical device portfolio.
Stark Pharma develops comprehensive Validation Master Plans (VMPs) and performs GAP assessments to evaluate the current validation state and align it with global regulatory expectations. We help remediate deficiencies and prepare for health authority audits.
Our validation strategies meet global regulatory standards including FDA, EU EMA, CDSCO, WHO, and ISO 13485. We proactively adapt to evolving compliance requirements.
We prioritize critical systems and processes using a risk-based methodology—minimizing cost and effort while ensuring complete compliance.
With experience spanning pharmaceuticals, biotechnology, and medical devices, we bring cross-functional insights into every validation project we manage.
+1 (732)760-5152
hr@starkpharma.com
