“Kellerman Consulting acted as a coach for our new QC employ, so we benefited from that together with the thriving planning to the SQF audit. We received a ninety eight% within the audit. That ought to converse for itself.
All discussions might be shut outcomes-orientated, and all challenges will be evaluated and documented intimately. As being a purchaser, you are going to acquire the report on the discussion. Presentation of the outcomes before other company Reps is possible on desire.
Even though these challenges are exterior variables can’t be controlled by any enterprise. The just one and only way to stay sustainable is by a structured Production Excellence Method.
We don’t just make sure your compliance Together with the laws; we equip you While using the information and applications to keep up this compliance. Believe in us to provide realistic, precise, and cost-helpful remedies tailor-made towards the unique GMP issues your Corporation faces.
Our pharmaceutical consulting Professionals will make a personalized technique depending on your product and firm’s individual requirements. Our regulatory compliance clientele include:
The proprietor and its contributors will not be responsible for any losses, injuries, or damages in the Exhibit or use of this details. Privateness Plan
This experience authorized Ana to gain an in-depth comprehension of the regulatory authorities’ anticipations and an extensive knowledge of the EU and US GMP polices. She’s also conducted GMP inspections to 3rd party international locations on EMA’s behalf.
Operating collaboratively, our regulatory specialists coordinate all areas of your demo’s doc assortment and submissions, which includes:
Besides parenterals PJC Pharma Consulting can present a wide range of guidance for other dosage kinds, from candidate variety as a result pharma consultants of to NDA/MAA submissions, both For brand spanking new chemical entities and solution line extensions (PLEs) of several oral dosage formulations: Tableting
Make certain more info the standard of your solutions by setting up a QMS. Valicare's industry experts will guidance you with QM consulting, doc preparation & implementation.
Laura with Kellerman Consulting is simply terrific. She is quite helpful, effortless to operate with and acquired us via our GMP audit by using a much better score than we expected. Also, the Firm of every one of the paperwork Kellerman Consulting furnished us with is great.
Creating IQVIA’s positions on vital trends in the pharma and everyday living sciences industries, that has a target EMEA.
Acquiring IQVIA’s positions on critical traits from the pharma and everyday living sciences industries, by using a give attention to EMEA.
Our pharma consultants learn how to companion with government, authorized, and conversation teams. Every RCA pharma consulting Expert will acquire a response that should be approved through the regulatory company and be reasonable to execute.