Kellerman Consulting came on the rescue for me following dealing with Yet another competitor who remaining me in the dead of night. I had been so relieved to locate a responsible, educated consulting company who could enable a different operator out in creating a full blown HACCP approach - and train me along just how!

We’ll function alongside you to definitely implement your GMP certification application, ensuring that you understand how to run it and that you simply go your next audit.

Regulatory Compliance Associates high-quality assurance services consist of excellent authorities with expertise spanning important companies and start-ups. Our pharmaceutical consulting firm appreciates firsthand how to realize, manage, and boost top quality. Finally, our regulatory compliance solutions staff excels in transferring ongoing advancement understanding in your Business.

We understand the complexities of functioning a lifestyle science business and possess locations of expertise that come with just about every facet of R&D, functions, regulatory affairs, quality, and producing.

Our pharmaceutical consulting Gurus will develop a custom made strategy based upon your item and corporation’s individual requirements. Our regulatory compliance consumers include things like:

Continued guidance: Our commitment to your Corporation doesn’t close Along with the supply of a consultation services. We believe in forging lasting partnerships, and as a result, we provide ongoing assist and instruction to be certain your lengthy-expression GMP compliance.

Whether you’re while in the product arranging, improvement or pharmaceutical lifecycle management phase or need a remediation tactic for a compliance disaster, Regulatory Compliance Associates will information you thru each individual pharmaceutical consulting action of your regulatory system.

Tetrahedron executed SOP to improve the Creation setting up decrease WIP reduction owing to lower get creation mismatch, Creating of small-Value automation for material managing.

Use our specialist finder tool to browse a variety of our consultant CVs. Like to specific your preferences straight? Use our expert research kind to tell us what type of source you're looking for.

Our benefits-pushed crew will produce and implement your GMP program, educate you and stay with you until eventually you go your GMP read more certification audit.

From the pharmaceutical and medical device business the Scope of Work (SOW) could vary. Some consultants desire employing a vague SOW with not Considerably depth, which may provide them with some latitude with the work anticipations.Nonetheless, this may also certainly be a clue to their deficiency of experience. Unfortunately, imprecise SOWs may result in frustrated purchasers that expected selected deliverables at the end of the task. An in depth SOW is an effective indication that you're using the services of a skilled FDA cGMP advisor. A superb SOW must have a start off date and an conclusion day (or a minimum of a fantastic estimated finish date). Some clients signal SOWs with the idea that the FDA GMP consultants will begin more info on their task right away or not take as long to finish the venture.

Get promotional materials to the lifetime sciences marketplace far more quickly, although lessening pitfalls and reducing charges, With all the EY Clever Reviewer.

Our pharma consultants learn how to lover with government, legal, and interaction teams. Each and every RCA pharma consulting Qualified will build a response that can be accepted via the regulatory agency and be realistic to execute.

This features as an example, qualification, validation and deviation or alter administration. The Hole analysis is really an Lively comparison of your proven current point out Together with the prerequisites specified by nearby or Intercontinental GMP restrictions.