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Our crew of professionals has productively carried out a lot of gap analyses in over the last twenty years and features this consulting provider for all GMP methods.
Though these worries are external components can’t be managed by any organization. The a person and only way to remain sustainable is by a structured Production Excellence Approach.
Continuity together with further availability in the course of capability intense company durations is ensured.
Our shoppers are hugely progressive biopharmaceutical corporations accomplishing remarkable issues. It’s amazing and often really complex science, and we’ve positioned ourselves right in the midst of the action, supporting therapeutic areas where by pioneers are undertaking the most exciting function.
Being aggressive and supplying the personalised knowledge that sufferers demand require life sciences corporations to locate new ways of Operating.
As Component of threat administration and on the basis of regulatory necessities, audits have to be performed by sufficiently experienced staff with the company or by 3rd events on web-site on the provider's premises or by the use of questionnaire audits, based on the criticality of the goods/services.
Our products and services are backed by a Total Good quality Assurance. If for almost any explanation, you will be dissatisfied with any support, We'll offer you a full refund.
Kellerman Consulting has supported countless clientele nationwide to effectively pass their regulatory inspections as well as their GMP and cGMP certification audits.
Partnering with Other individuals to share information, drugs and means while anticipating tendencies and regulatory adjustments can help assure sustainability during the increasingly proof-primarily based, results-focused sector.
Read through our trends report from the few years back to evaluation get more info important pharma considerations that are still at Engage in in the market.
Our good quality, manufacturing, CAPA, and provider high-quality industry experts perform complete approach assessments and analyses read more to make certain all compliance gaps are shut it doesn't matter where by They could be.
On-connect with true-time assistance in the course of your GMP audit and ongoing guidance following the audit right until you will be Qualified, regardless of the.
We produce customized jobs in compliance with FDA / USDA regulatory requirements and GMP certification prerequisites For each and every company we provide.