Get qualified aid at just about every phase from the product lifecycle. We help existence science companies rapidly entry the marketplace's greatest consultants, contractors, and candidates. Our assets support in each stage with the products lifecycle.
We will critique your documentation and pay a visit to your facility, determine gaps in your existing system and facility operations, and we will help you fill These gaps in an effort to move your audit.
To remain forward of opponents and travel preferred business outcomes, providers have to think about their operations and processes holistically in reaction to evolving marketplace Levels of competition and digital know-how disruption.
You may withdraw your consent to cookies at any time after getting entered the website through a backlink during the privacy plan, which you can uncover at The underside of each web page on the web site.
Our pride lies not simply inside the variety of companies we provide but additionally during the individuals who provide these expert services. Many our GMP consultants are seasoned gurus which have served as GMP inspectors and also have a wealthy historical past of navigating the demanding environment of pharmaceutical laws.
Take a look at specialist CVs » Begin a advisor look for » Join our consulting staff. Within the FDA Group, we have been generally looking for prime expertise to grow our community. If you're able to provide knowledge and new perspectives to our consulting team, we invite you to definitely pharma consultancy mail us your resume.
We've been able to not only being familiar with these world polices, but additionally of furnishing strategic alternatives that take note of both of those worldwide and local compliance necessities.
Confident supply chain with experienced suppliers and robust procedures is finally The premise for decreasing issues and guaranteeing medicinal item protection.
Previously during improvement and formulation, the very first compliance steps for Good Production Exercise (GMP) need to be implemented. These basically involve all GMP applicable matters which can be to get applied on a possibility-dependent tactic based on the respective advancement phase.
This and the precise description of the requirements and procedures makes it possible for the ample adaption from the instruments to the true require of your respective GMP system.
Laura with Kellerman Consulting is just great. She is extremely valuable, effortless to work with and acquired us through our GMP audit using a significantly better rating than we predicted. Also, the Corporation of the many here paperwork Kellerman Consulting furnished us with is great.
STRATEGIC DRUG Progress Generate system by way of pro regulatory insight and suggestions Industry-major therapeutic and practical location experts assist clientele glean related regulatory insights from world-class facts, enabling real-time determination and evaluation of your time, cost and hazard.
You'll be able to commission us Using the comprehensive conception and document generation on your QMS or have our specialists accompany or put into action the processing of particular person focal factors.
Our specialists get ready all key regulatory submissions and supply intensive quality control review for all demo-associated documentation, like: