The aim of supplier qualification is, within the one hand, to safeguard supply chains all through the solution lifecycle and, on the other hand, to make certain sturdy internal procedures in compliance Together with the applicable regulatory needs.

All conversations is going to be shut success-orientated, and all difficulties is going to be evaluated and documented intimately. To be a customer, you may get the report of your discussion. Presentation of the outcomes before other company Associates is achievable on need.

KNORS team of pharma professionals rationally structure quality management units and assistance to employ by trainings.

We don’t just assure your compliance With all the restrictions; we equip you Using the expertise and instruments to take care of this compliance. Believe in us to provide simple, precise, and value-productive methods tailored for the unique GMP troubles your Firm faces.

GMP Expert comprehends your item and plans the ability in accordance with international regulatory criteria.

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with sector authorities seasoned in complexities of your pharmaceutical and biopharmaceutical industries.

Kellerman Consulting workforce users are held up-to-date on every single challenge, to ensure any one of our consultants can certainly move in at any moment to supply you with the reliability and responsiveness your venture deserves.

Our companies are backed by a complete Top quality Promise. If for almost any purpose, that you are dissatisfied with any service, We are going to give you an entire refund.

Along with parenterals PJC Pharma Consulting can provide an array of guidance for other dosage types, from prospect assortment by to NDA/MAA submissions, both equally For brand new chemical entities and product or service line extensions (PLEs) of quite a few oral dosage formulations: Tableting

That has a GMP consultant on board, your Firm can focus on its core operations although making certain compliance is meticulously taken care of.

Tim and Brian rallied all around me and designed absolutely sure I more info was ready to fulfill the problem head on. From writing and reviewing files, to educating a complete amateur, to undertaking a mock audit upfront, the Kellerman team built certain we ended up Prepared not simply to move, but to score a 91 on our initial audit. I couldn't recommend them more extremely”!

Consultants get ready the place e-book, which contains correct and specific information regarding each area specifically.

As these paperwork are the important to an economical and mistake absolutely free operation of the GMP device, they must in shape to one another and also to the size of the customer facet.

“They are really so Qualified and it had been just an actual enjoyment Functioning via every little thing. I'd absolutely propose Kellerman Consulting. I have already got. When men and women talk to me with regard read more to the SQF consulting approach, I would not be reluctant to state," certainly call Kellerman Consulting'' ” .