An Unbiased View of pharma consultancy

Do you want assist or tips on one or more of these subjects? Our knowledgeable gurus will accelerate the entry of your respective item in the pharmaceutical/biotech market.

We have an understanding of the assorted difficulties and difficulties you encounter with your way to obtaining GMP compliance within the pharmaceutical, biotechnology, ATMP and healthcare gadget producing industries - and we create sensible, achievable and price-efficient solutions for you.

- And when on-web-site visits are not possible, our adaptable shipping design permits us to guarantee business continuity and the bottom doable impact on all auditing functions, we complete audits remotely by means of documentation evaluations and SME conversations as per Pharmexpert methodology. And When onsite audit feasible, We program for onsite audit.

Hence, all supplier qualification steps lead to the general targets of medicinal solution protection, efficiency and compliance.

Our pharmaceutical consulting Experts will produce a tailored tactic based upon your merchandise and organization’s unique demands. Our regulatory compliance clientele include:

Provider Qualification The good producing observe surroundings involves qualification of suppliers to ensure drug high quality and safety

We comprehend your product and prepare the ability in accordance with Worldwide regulatory benchmarks. The GMP certification consultation involves documentation and team training in addition to facility structure.

Regulatory Compliance Associates pharma regulatory consultants will acquire a comprehensive proof book of documented evidence demonstrating the corrective motion taken to remediate non-compliant troubles.

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I couldn’t have asked for a greater corporation that will help us Focus on our certification. They were beneficial, academic, and bought our software successfully transformed with clear professionalism.

Tim and Brian rallied about me and built guaranteed I used to be willing to meet up with the challenge head on. From composing and examining documents, to educating a whole novice, to undertaking a mock audit in advance, the Kellerman group website made certain we have been All set don't just to go, but to score a ninety one on our first audit. I could not recommend them much more extremely”!

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“They may be so Qualified and it was just a real pleasure Doing the job as a result of every little thing. I might Certainly suggest Kellerman Consulting. I have already got. When people inquire me with regard to the SQF consulting process, I wouldn't wait to say," unquestionably simply call Kellerman Consulting'' ” .