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Deciding on a GMP guide is a critical choice which will form your compliance journey and impression the overall success of your organization.
Alex has held management level roles in High-quality Assurance, making certain item high quality & regulatory compliance, in addition to Senior Technical Manager positions chargeable for CMO administration, oversight and tech-transfer of pharmaceutical solutions. This working experience equips him effectively in evaluating producing techniques for early section merchandise, as well as late phase and business products for EU and US marketplaces.
Kellerman Consulting has supported many hundreds of shoppers nationwide to properly pass their regulatory inspections and their GMP and cGMP certification audits.
Our success-driven group will compose and put into action your GMP program, prepare you and stay with you until eventually you move your GMP certification audit.
A crew of long lasting GMP consultants, specialised in various fields of competence, supports you with your duties and problems with experience and foresight.
Getting in compliance with GMPs or cGMPs is just not the same as staying Accredited. As a way to get GMP or cGMP certification, you should retain the services of a third-celebration auditing company To judge your tactics against GMP or cGMP benchmarks.
A GMP consultant offers the specialist steerage important to navigate the complexities of GMP compliance. Their in depth familiarity with neighborhood and international regulations, field most effective procedures, and the newest updates in the sector equips your Firm With all the equipment to satisfy click here and exceed regulatory benchmarks.
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