By using a combined tenure across our corporations of practically 200 decades and our market-regarded scientific and technological knowledge, we aid to ensure the basic safety of more than a hundred ninety million clients and healthcare practitioners world wide annually.
The pharmaceutical sector is ruled by stringent restrictions to ensure the protection, efficacy, and high-quality of goods. Superior Producing Exercise (GMP) compliance is non-negotiable and it is central to the operational accomplishment of any Firm In this particular sector.
Owing to our in depth staff of consultants, we tend to be ready to perform the requested Hole Assessment in the timely fashion.
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Regulatory Compliance Associates Good quality consulting contains assessments, tactic, implementations, employees augmentations, and identification of excellent metrics to ensure ongoing enhancement. Our pharma consultants comprehend the strategic wondering necessary to align your business requirements and plans.
This encounter permitted Ana to get an in-depth understanding of the regulatory authorities’ expectations and an extensive familiarity with the EU and US GMP rules. She’s also carried out GMP inspections to 3rd party nations on EMA’s behalf.
Legislation firms in search of pharmaceutical consulting agency know-how within the remediation of warning letters, consent decrees, 483’s or import bans
Kellerman Consulting has supported countless shoppers nationwide to correctly pass their regulatory inspections and their GMP and cGMP certification audits.
Throughout your cost-free GMP consultation, you’ll discover what the requirements are for finding Qualified, how much it charges without having concealed expenses, how long it will require, And the way our process is effective to assure you pass your GMP certification audit on the initial check out.
Kellerman Consulting does an awesome position of consistently meeting prospects’ expectations and taking time to be familiar with the desires of their one of a kind purchaser. Their services goes above and past expectations.
Rely on our skills from owning aided our consumers go a huge selection of GMP audits. Our GMP consultants will manual your staff to good results.
A GMP advisor offers the pro steering necessary to navigate the complexities of GMP compliance. Their considerable familiarity with nearby and Intercontinental check here polices, marketplace very best procedures, and the newest updates in the field equips your Corporation Together with the equipment to satisfy and exceed regulatory expectations.
Establishing IQVIA’s positions here on important traits within the pharma and lifetime sciences industries, that has a concentrate on EMEA.