Which has a combined tenure throughout our organizations of virtually 200 decades and our sector-acknowledged scientific and technological abilities, we assist to ensure the safety of about a hundred ninety million clients and Health care practitioners around the globe each and every year.
In addition, Each individual Regulatory Compliance Associates pharma consulting Professional understands compliance enforcement. We’ll put together an extensive pharma consulting strategy to support inside your remediation attempts, travel ongoing enhancement, and manage regulatory compliance with the rules.
Proprietary talent array of previous FDA and industry pros amplified by a company culture of responsiveness and execution. About Overview
We don’t just ensure your compliance Using the rules; we equip you While using the awareness and resources to take care of this compliance. Have confidence in us to provide functional, specific, and cost-successful remedies tailored into the distinctive GMP issues your Group faces.
Kellerman Consulting held my hand each and every action of the best way (and rely on me I needed it)! Kellerman Consulting got me by means of all of my approvals with an straightforward to follow HACCP strategy that appeased a USDA regional supervisor.
Christina Sanchez Miller, MPH has above 20 years of administration, biologics, good quality assurance and study knowledge inside the clinical area. She's a published author in scientific publications, click here papers and it has introduced at a number of Worldwide conferences.
As Portion of threat management and on The premise of regulatory requirements, audits must be completed by sufficiently experienced personnel through the manufacturer or by third get-togethers on web site at the supplier's premises or through questionnaire audits, with regards to the criticality of the products/companies.
Style, design, and commercialization of cleanroom facilities are highly-priced processes that require thorough organizing and means. Additionally, it dictates the quality and compliance of products which are for being manufactured as well as their profitability around the long run.
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Regardless of whether you’re while in the merchandise planning, enhancement or pharmaceutical lifecycle administration stage or require a remediation approach for any compliance disaster, Regulatory Compliance Associates will guideline you thru just about every pharmaceutical consulting stage of the regulatory course of action.
We've concluded over seven hundred+ Seller/Provider Qualification audits. Regionally based consultants in broader geography so powerful top quality of labor devoid of language barrier and read more journey restrictions.
Get in contact with us now and notify us where techniques of GMP idea improvement you'll need guidance. We are going to immediately offer you a suggestion for consulting solutions or development of an idea. Jointly we discover the ideal solutions in your undertaking!
We can give GMP products and services for individual area of interest answers for your worries together with in depth deals that protect all GMP specifications arising from the context of pharmaceutical producing things to do.