“Kellerman Consulting acted as being a coach for our new QC seek the services of, so we benefited from that as well as the thriving planning for the SQF audit. We obtained a ninety eight% around the audit. That should communicate for alone.
You reap the benefits of the assist of GMP consultants who evaluate each project like a staff. The co-founders of Kellerman Consulting are associated with Each individual undertaking at each and every stage to make sure that we've been delivering on our dedication to our purchasers.
We guarantee coherent programs are associated with development and commercial objectives, aligned with the latest Strategies and rising technologies and regulatory necessities. Created upon a profession’s worth of producing and advancement experience, we can easily support you in enabling your products and solutions to development to industry a lot quicker which has a ‘suitable very first time’ solution.
Kellerman Consulting’s GMP consultants offer a penned excellent & food items protection handbook that is certainly tailor-made on your solution, approach and operation. We provide high-quality consulting and food stuff security teaching As outlined by latest FDA regulatory needs and custom made into the GMP certification plan that you're wishing to acquire Accredited towards.
Our delight lies not just while in the choice of solutions we offer and also during the individuals who deliver these companies. Quite a few our GMP consultants are seasoned pros which have served as GMP inspectors and have a wealthy heritage of navigating the difficult globe of pharmaceutical restrictions.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting organizations with marketplace authorities knowledgeable in complexities from the pharmaceutical and biopharmaceutical industries.
Considerable preparation of Guidelines: Our experts create in depth Guidelines for all vital top quality assurance tools.
We can create basic engineering prototypes that happen to be tailored towards your useful and placement desires and propose Value-efficient answers that adjust to regulatory specifications. The next get more info undertaking definitions will probably be described during standard engineering:
We are able to thus provide you with this consulting service in Each and every method standard in the market. The look overview can usually be performed without a corresponding on-web site presence, exclusively depending on the technical documentation about the final and in-depth arranging of an installation.
Our final results-pushed workforce will compose and implement your GMP plan, train you and stick with you till you pass your GMP certification audit.
A staff of everlasting GMP consultants, specialised in various fields of competence, supports you with your jobs and issues more info with abilities and foresight.
STRATEGIC DRUG Growth Push tactic through professional regulatory insight and assistance Sector-major therapeutic and practical area experts help consumers glean pertinent regulatory insights from world-class information, enabling true-time determination and evaluation of your time, Price and hazard.
In administration consulting discipline, IT consultants assist clientele clear up business enterprise and operational challenges with the implementation of data Technologies
We build custom assignments in compliance with FDA / USDA regulatory demands and GMP certification specifications For each small business we serve.