Kellerman Consulting arrived into the rescue for me just after working with A further competitor who left me in the dark. I was so relieved to locate a dependable, proficient consulting business who could help a fresh operator out in developing an entire blown HACCP prepare - and train me alongside the best way!
You get pleasure from the support of GMP consultants who review just about every undertaking being a staff. The co-founders of Kellerman Consulting are associated with Each and every challenge at each individual stage to make certain that we've been providing on our dedication to our shoppers.
Our pharmaceutical consulting Authorities will develop a customized technique according to your products and business’s individual wants. Our regulatory compliance consumers incorporate:
The rules system surrounding pharmaceutical companies is usually tricky for even the most skilled sector veteran to understand. Just one misstep could suggest important and lasting penalties for your organization.
GMP consultants not merely help preserve compliance, but Additionally they identify potential regions of danger ahead of they develop into substantial concerns.
You may acquire job administration providers and We are going to stay with you till you move your audit – regardless of the.
A different breed of therapies is coming into clinical development. Make sure that your method of drug improvement is as modern given that the compound you want to convey to marketplace.
With in excess of 20 years of expertise with FDA, Health and fitness copyright, EU and worldwide regulatory businesses worldwide, Regulatory Compliance Associates® gives primary pharmaceutical consultants. We’re one of several couple pharma consulting businesses which can help you navigate the issues linked to marketplace laws.
With read more greater than 20 years of expertise with FDA, Well being copyright, EU and world-wide regulatory agencies worldwide, Regulatory Compliance Associates® features foremost pharmaceutical consultants. We’re among the list of number of pharma consulting corporations that will help you navigate the problems related to business polices.
The medications and pharmaceuticals marketplace in India has emerged as considered one of the biggest sectors, garnering a check here promoting growth of nine.
Most FDA GMP consultants will have GMP consulting practical experience which is an important qualification since they've experienced prospects to work with quite a few businesses and in various configurations. The significance of operational practical experience, nevertheless, really should not be missed.
Being an extension of one's GMP Auditing team, we’re in the position to perform audits on your behalf, using your recognized audit application or perhaps the ADAMAS approach, whichever is effective most effective for your needs.
Superior Production Methods (GMPs) can also be called prerequisite programs, or meals safety and high quality fundamentals. They're the website and firm specific regulations and day by day actions place into place to hold products and solutions Risk-free. GMPs could be created down or communicated verbally and therefore are frequently enforced by Top quality Assurance or administration personnel.
We are able to give GMP expert services for specific area of interest remedies for the worries and comprehensive offers that include all GMP necessities arising inside the context of pharmaceutical producing things to do.