We presents turnkey quality options and concentrates on providing Remarkable cost success, whilst preserving highest good quality requirements for our Clients.
We recognize the diverse troubles and difficulties you facial area on your own technique to achieving GMP compliance in the pharmaceutical, biotechnology, ATMP and healthcare product producing industries - and we develop simple, achievable and cost-helpful remedies for yourself.
Regulatory Compliance Associates top quality assurance solutions involve top quality industry experts with working experience spanning important corporations and start-ups. Our pharmaceutical consulting organization appreciates firsthand how to achieve, sustain, and make improvements to good quality. Lastly, our regulatory compliance services crew excels in transferring continual advancement knowledge to the Firm.
Kellerman Consulting’s GMP consultants give a composed quality & food items safety guide that's tailor-made towards your item, method and operation. We offer high-quality consulting and food stuff safety coaching according to present-day FDA regulatory requirements and personalized on the GMP certification plan that you'll be wishing to get Licensed versus.
Just before this, an acceptable top quality administration method need to have already been proven, which demonstrates suited actions to guarantee the appropriate top quality and basic safety of your medicinal items In line with EU expectations.
Together with your written food protection & top quality plan, Each one of our purchasers receives use of a package deal of staff food items protection coaching movies, quizzes, and instruction logs that aren't publicly out there at no supplemental cost in the two English and Spanish.
The pharmaceutical discipline is filled with confidential data, from affected individual information to demo success to patented function; it is totally essential to shield this data and IP from any cybersecurity danger.
Assured provide chain with capable suppliers and strong click here processes is in the long run the basis for minimizing grievances and making certain medicinal product or service safety.
With lean manufacturing marketing consultant, enterprises and industries can encounter our sustainable method of scale their organization.
We assistance web-site for properly passing inspections and design and style put up-inspections remediation options to ascertain & upgrade GMP compliance and sustain approval for your products with Pharmexpert's personalized and cost-efficient programs for Top quality Administration for Pharmaceuticals, Bio-Pharma and MD.
Tim and Brian rallied close to me and manufactured sure I used to be prepared to meet up with the challenge head on. From producing and reviewing documents, to educating a complete novice, to executing a mock audit upfront, the Kellerman workforce made guaranteed we had been Completely ready not merely to pass, but to attain a ninety one on our initial audit. I could not advocate them much more very”!
Depend on our know-how from possessing helped our purchasers pass hundreds of GMP audits. Our GMP consultants will information your team to good results.
M&A Realize continuously greater returns with a systematic and repeatable method of mergers and acquisitions
Our experts pharma consultants in India get ready all important regulatory submissions and supply substantial good quality control assessment for all demo-related documentation, including: