The Basic Principles Of GMP consultancy
The Basic Principles Of GMP consultancy
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Kellerman Consulting arrived for the rescue for me just after dealing with another competitor who left me in the dead of night. I used to be so relieved to locate a responsible, experienced consulting organization who could help a different operator out in establishing a complete blown HACCP approach - and educate me together the way in which!
We'll overview your documentation and visit your facility, recognize gaps with your present program and facility functions, and we will allow you to fill Those people gaps in order to pass your audit.
Custom made products and services for every system, with customized procedures intended to fulfill extremely precise requirements. We’ve learned a great deal about what performs and what doesn’t. Search the newest learnings and insights from our scientific growth pros.
GMP consultants foster an atmosphere of continuous enhancement within just your Firm. They provide schooling and aid to ensure that your group is up-to-date with the newest compliance specifications.
Qualification of premises, facilities and equipment plus the planning of the corresponding documentation
Ongoing support: Our motivation for your Business doesn’t conclusion Together with the delivery of the consultation provider. We believe in forging lasting partnerships, and therefore, we offer ongoing support and instruction to make certain your lengthy-term GMP compliance.
We produce excellent leaders who staff to deliver on our promises to all of our stakeholders. In so undertaking, we Perform a critical purpose in developing a better Performing entire world for our individuals, for our clients and for our communities.
Legislation corporations looking for pharmaceutical consulting business knowledge during the remediation of warning letters, consent decrees, 483’s or import bans
Now we have an A ranking with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for all the things they have got accomplished to assist our enterprise to website obtain the certification. Their First assessment of our corporation, the documents, and information presented to create our
Offering a strategic blend of business get more info acumen, international compliance, and therapeutic expertise that will help make sure your innovative Thoughts aren’t hindered by limited means.
Whether or not you’re inside the product or service setting up, advancement or pharmaceutical lifecycle management stage or have to have a remediation strategy for your compliance disaster, Regulatory Compliance Associates will information you through every single pharmaceutical consulting stage of the regulatory approach.
- Becoming a member of our IGAP plan/ Audit report library is free for suppliers/manufacture. Our experienced and certified auditor will execute total web-site audit of provider masking large quantity of molecules/merchandise (if not presently carried out) without having charge to supplier and in-depth audit report shall be well prepared.
On-phone authentic-time assist during your GMP audit and ongoing aid after the audit until you happen to be Accredited, regardless of the.
We could offer you GMP products and services for particular person area of interest methods in your worries together with detailed packages that protect all GMP specifications arising during the context of pharmaceutical production routines.