Throughout the merchandise life cycle of a medicinal product, high-quality needs enhance continually from investigate and growth by different clinical phases to market maturity.
We're going to evaluation your documentation and stop by your facility, identify gaps inside your current program and facility operations, and we will assist you to fill Individuals gaps in an effort to go your audit.
Legislation firms in search of pharmaceutical consulting firm expertise from the remediation of warning letters, consent decrees, 483’s or import bans
Kellerman Consulting’s GMP consultants offer a written high quality & foods basic safety handbook that is personalized for your product, approach and Procedure. We provide good quality consulting and foods security education In keeping with current FDA regulatory needs and custom made to your GMP certification scheme that you are wishing for getting certified in opposition to.
Kellerman Consulting held my hand every step of the way in which (and trust me I necessary it)! Kellerman Consulting acquired me through all of my approvals having an straightforward to follow HACCP strategy that appeased a USDA regional manager.
Be sure to decide on an sector from the dropdown checklist We operate with formidable leaders who want to define the future, not hide from it. Jointly, we realize incredible results.
which were critical into the successful completion of this method. I might very suggest Kellerman Consulting for any of your respective consulting needs because they ended up quite Qualified and ensured that every one goods have been dealt with prior to our audit. “
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting organizations GMP consultants with field gurus professional in complexities in the pharmaceutical and biopharmaceutical industries.
Not merely did our audit rating here reflect how fantastic their process works, but I also gained so a great deal more understanding of SQF and self esteem as an excellent Supervisor!”
"Its a long set up incontrovertible fact that a reader will likely be distracted through the readable content of a webpage when"We have been happy to tell that one particular very expert." For just about any requirement relating to on-web site, compose to us at [email protected] OR Simply call AT 9878880408
Regulatory Compliance Associates high-quality assurance providers include things like high-quality specialists with expertise spanning main companies and begin-ups. Our pharmaceutical consulting company is aware of firsthand how to realize, retain, and boost excellent. Last but not least, our regulatory compliance services team excels in transferring steady improvement understanding to the Business.
- Becoming a member of our IGAP program/ Audit report library is free for suppliers/manufacture. Our seasoned and experienced auditor will carry out full web page audit of supplier covering massive range of molecules/items (if not already performed) without having cost to supplier and detailed audit report shall be well prepared.
A GMP specialist delivers the specialist direction needed to navigate the complexities of GMP compliance. Their considerable expertise in neighborhood and Worldwide regulations, business finest methods, and the newest updates in the sector equips your Firm With all the instruments to satisfy and exceed regulatory specifications.
It’s a pharma consultancy Established by regulatory compliance executives through the pharmaceutical field. Each and every pharmaceutical sector guide about the Regulatory Compliance Associates group is aware of the one of a kind internal workings from the regulatory approach.