Kellerman Consulting arrived for the rescue for me after dealing with A different competitor who left me in the dead of night. I had been so relieved to locate a accountable, proficient consulting firm who could support a brand new operator out in creating a full blown HACCP plan - and train me together just how!

We realize the diverse issues and troubles you confront on the approach to reaching GMP compliance during the pharmaceutical, biotechnology, ATMP and healthcare machine production industries - and we build practical, achievable and cost-effective solutions to suit your needs.

Nearly all of our all-natural experts and engineers are knowledgeable about staying in management positions and, if expected, also in just your organization.

We don’t just make certain your compliance with the laws; we equip you With all the understanding and tools to take care of this compliance. Rely on us to provide sensible, exact, and cost-effective alternatives tailor-made on the unique GMP problems your organization faces.

Our pharmaceutical consulting Specialists will produce a tailored method determined by your products and firm’s personal desires. Our regulatory compliance consumers contain:

Christina Sanchez Miller, MPH has around 20 years of management, biologics, high quality assurance and analysis knowledge from the health care area. She's a printed author in scientific textbooks, papers and has presented at several Global conferences.

This expertise permitted Ana to achieve an in-depth knowledge of the regulatory authorities’ expectations and an extensive familiarity with the EU and US GMP polices. She’s also done GMP inspections to third party nations on EMA’s behalf.

This is certainly creating a power shift with new entrants (normally not driven by earnings) disrupting the incumbents.

The EY R&D Workbench for Pharma is a unique tech Answer for productive undertaking arranging management, workflow and challenge and query monitoring in GMP consultants the R&D setting.

Supplying a strategic combination of business acumen, world-wide compliance, and therapeutic knowledge that will help be certain that your impressive ideas aren’t hindered by limited assets.

Firsthand.co per year invites all consultants in a specific location to rank top consulting firms in that space. The score is based on The proportion of consultants voting for your organization. The consultants can vote for up to 3 corporations and may not vote for their very own.

The applicable supervisory authority checks the legally compliant structure within your QMS and will only grant your business a authorization for the exercise in dilemma if all processes are described in compliance With all the polices.

Our High more info quality program make sure that our customers acquire individualized experiences with areas most pertinent to their operations.

Previous to the introduction of medicinal items to the industry, the laws of Good Apply (GxP) ought to be adopted in the course of output and development.