How GMP consultants in India can Save You Time, Stress, and Money.
How GMP consultants in India can Save You Time, Stress, and Money.
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Regardless of whether you’re within the product setting up, advancement or pharmaceutical lifecycle management stage or require a remediation tactic for your compliance disaster, Regulatory Compliance Associates will tutorial you thru each individual pharmaceutical consulting step of the regulatory procedure.
In fact, it might just be much too cumbersome and costly to produce any significant alterations to the facility style or design after it's done and is becoming operational if mistakes are discovered or worse, regulatory agencies deny its approval for manufacturing.
As your husband or wife, we are able to negotiate the possible assessment minefield of regulatory compliance products and services with Perception, hindsight, and the distinct benefit of our breadth and depth of knowledge and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs services for pharmaceutical companies.
Kellerman Consulting’s GMP consultants offer a penned quality & meals security guide that's tailored to your item, system and Procedure. We provide top quality consulting and food items basic safety instruction In accordance with latest FDA regulatory requirements and custom made to the GMP certification scheme that you'll be wishing to get Licensed towards.
GMP Guide comprehends your item and programs the facility in accordance with Intercontinental regulatory standards.
Remember to choose an field in the dropdown record We do the job with formidable leaders who want to determine the longer term, not conceal from it. Alongside one another, we realize remarkable results.
This experience allowed Ana to get an in-depth knowledge of the regulatory get more info authorities’ expectations and an extensive familiarity with the EU and US GMP polices. She’s also done GMP inspections to 3rd party nations on EMA’s behalf.
This practical expertise, coupled with our extensive comprehension of area and global rules, positions us as an unmatched asset to any Firm trying to find GMP compliance.
We've got an A rating with BRCGS And that i attribute that to Brian Kellerman and Kellerman Consulting for everything they have done to assist our enterprise to get the certification. Their First assessment of our enterprise, the paperwork, and data delivered for making our
I couldn’t have questioned for a far better firm to help you us work on our certification. They have been valuable, educational, and acquired our method effectively converted with very clear professionalism.
We fully grasp the complexities of managing a existence science company and get more info possess places of expertise that include each individual aspect of R&D, functions, regulatory affairs, quality, and production.
The suitable supervisory authority checks the legally compliant layout within your QMS and might only grant your business a authorization for that action in problem if all procedures are described in compliance Along with the restrictions.
Have to have to build or augment your Good quality Assurance group with leading expertise? We aid 1000s of lifestyle science providers outsource their QA jobs and fill specialised roles through convenient staff members augmentation and recruitment.
It’s a pharma consultancy founded by regulatory compliance executives within the pharmaceutical sector. Each individual pharmaceutical market specialist over the Regulatory Compliance Associates group knows the exclusive inner workings on the regulatory approach.