Whether or not you’re from the product setting up, progress or pharmaceutical lifecycle administration stage or need a remediation tactic for the compliance disaster, Regulatory Compliance Associates will manual you thru each pharmaceutical consulting stage of your regulatory system.
“We partnered with Kellerman Consulting pretty early on during the SQF certification approach, and by depending on their expertise and methodical approach to gathering, compiling, and Arranging the essential documentation, we ended up prosperous in attaining our certification.
Our mission will be to accelerate innovation for any healthier planet. Together, we are able to fix shopper problems and make improvements to affected person lives.
Our interim professionals are extremely versatile, and their get the job done is billed on hourly foundation only. A set value provide which include all incidentals might be submitted on Particular ask for.
Previous to this, an proper high-quality administration technique will have to have already been set up, which demonstrates suitable actions to make sure the appropriate quality and protection on the medicinal merchandise In keeping with EU specifications.
You will acquire venture administration providers and We are going to stay with you till you go your audit – it doesn't matter what.
The highest pharmaceutical consulting corporations include huge names similar to the MBB, the massive four, in addition to healthcare/pharma precise consultancies like ClearView and IQVIA. This information will give short definitions and rankings of ideal pharmaceutical consulting corporations while in the business.
With a lot more than 20 years of working experience with FDA, Well being copyright, EU and world-wide regulatory agencies all over the world, Regulatory Compliance Associates® features foremost pharmaceutical consultants. We’re one of several here couple of pharma consulting companies that can help you navigate the worries connected to industry rules.
Don't just did our audit rating replicate how terrific their program works, but I also acquired so far more comprehension of SQF and self confidence as a Quality Supervisor!”
The modern period around the state of artwork production services (earth-course facility) is designed and produced in accordance with strict cGMP prerequisites.
We realize the complexities of jogging a everyday living science organization and possess places of experience that come with just about every facet of R&D, functions, regulatory affairs, excellent, and manufacturing.
Our high-quality, production, CAPA, and supplier website quality gurus conduct extensive process reviews and analyses to be sure all compliance gaps are closed it does not matter in which they may be.
Our pharma consultants know how to lover with executive, lawful, and communication groups. Each and every RCA pharma consulting Professional will build a reaction that can be approved with the regulatory company and become sensible to execute.
With over 20 years of working experience with FDA, Overall health copyright, EU and world wide regulatory businesses worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of many few pharma consulting corporations that will help you navigate the troubles linked to business restrictions.