Laura with Kellerman Consulting is just terrific. She is rather valuable, easy to operate with and obtained us through our GMP audit using a a lot better rating than we predicted. Also, the Firm of each of the documents Kellerman Consulting furnished us with is excellent.
GMP only suggests excellent producing practices. As described by WHO “GMP is comprehended to generally be that element of high quality assurance that assures that merchandise are continually produced and regulated to your criteria of good quality appropriate to their predicted use and as specified through the marketing and advertising authorization”.
- The audit report shall be then offered inside our Audit report database which can be accessible to any of your purchasers. We'll obtain authorization in the provider in advance of sharing stories into the customers.
Draw on our considerable subject matter abilities to get a shortlist of candidates screened to suit your prerequisites.
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Our mission is to speed up innovation for the healthier entire world. Alongside one another, we can easily remedy buyer issues and strengthen patient life.
Regardless of your next challenge, our GMP consultants get the job done closely with our Architects, Engineers, Experts and ex production employees that will help design and style your future job, we routinely get the job done with exterior contractors, tools suppliers and builders.
Use our dedicated group for support with procedure validation and regulatory affairs, that will help your reagent transition from initial submission to sector authorization. We’ll deliver total documentation each and every stage of this way.
Unparalleled expertise: Our consultants have large market working experience and an insider’s standpoint from their time as GMP inspectors. They have stood on either side from the GMP compliance equation, delivering them with a singular knowledge that informs every single support we provide.
Aggressive Edge: GMP certification differentiates your model from opponents, positioning you being a reputable and liable choice available in the market.
As your partners, we check here can negotiate the prospective minefield of regulatory compliance and regulatory research with Perception, hindsight, as well as clear advantage of our special know-how and knowledge.
How will obtaining GMP certification with all your advice elevate our manufacturer track record and instill confidence within our shoppers?
If you already have a facility style and design, we can provide an unbiased GMP assessment to be sure that the many critical aspects are covered.
Engagement Model Consulting Initiatives Put your projects while in the fingers website of capable 3rd-occasion authorities. Undertaking-based mostly consulting engagements are executed by a person or crew of specialised assets.