Regardless of whether you’re inside the solution setting up, advancement or pharmaceutical lifecycle administration phase or have to have a remediation method for any compliance disaster, Regulatory Compliance Associates will guidebook you through just about every pharmaceutical consulting step of your regulatory system.
Whether or not you'll need staff compensation for parental leave or for other brief-term vacancies - we offer you the ideal interim manager for every necessity profile.
Regardless if you are ranging from scratch, or else you’d like us to include your present systems, we’ll produce the program you might want to get certified.
GMP consultants foster an ecosystem of ongoing advancement inside your Firm. They provide teaching and assist to ensure that your workforce is up to date with the latest compliance expectations.
Qualification of premises, amenities and equipment in addition to the preparation on the corresponding documentation
“Kellerman Consulting was Expert, economical, and continues to point out their help and guidance even following the GMP audit”.
We comprehend your item and approach the power in accordance with Worldwide regulatory benchmarks. The GMP certification consultation consists of documentation and personnel training In combination with facility design and style.
Regardless of your future check here venture, our GMP consultants function read more closely with our Architects, Engineers, Researchers and ex manufacturing employees to help you style and design your upcoming undertaking, we routinely work with exterior contractors, products suppliers and builders.
Built-in Asset Growth Replacing staged, siloed drug progress with cross-practical convergence via system and organizational improve to determine product benefit.
Upon request, the respective regulatory authority will perform an on-web-site inspection to validate compliance with national law and EU GMP demands.
As the marketplace grows larger and competitive, the war for top quality talent is getting momentum. This calls for Skilled skills in pinpointing, sourcing and interesting potential-Prepared expertise.
Rely on our knowledge from owning aided our purchasers go numerous GMP audits. Our GMP consultants will guide your crew to accomplishment.
Fantastic Production Methods (GMPs) will also be often called prerequisite packages, or food stuff safety and high-quality fundamentals. These are typically the site and corporation precise rules and daily functions put into place to retain items Safe and sound. GMPs may be penned down or communicated verbally and are commonly enforced via High-quality Assurance or administration staff.
We create custom tasks in compliance with FDA / USDA regulatory needs and GMP certification necessities for every business we serve.