At Regulatory Compliance Associates, we provide the pharma consulting practical experience and pharma consultants required to guidebook you with the high-quality compliance process.
“We partnered with Kellerman Consulting pretty early on within the SQF certification process, and by counting on their know-how and methodical approach to amassing, compiling, and Arranging the required documentation, we have been thriving in getting our certification.
Our pharmaceutical consulting Authorities will make a customized method dependant upon your product and company’s specific desires. Our regulatory compliance clientele include:
We comprehend the complexities of managing a lifetime science business and possess spots of expertise that include just about every side of R&D, operations, regulatory affairs, top quality, and production.
In administration consulting, pharmaceutical consulting firms help on the event & gross sales of medications & pharmaceuticals. Consultants have specialist information on marketplace laws so they can support and much better allow firms to proficiently produce health-related solutions.
Additionally, each Regulatory Compliance Associates pharma consulting Specialist understands compliance enforcement. We’ll put together an extensive pharma consulting technique to help in your remediation attempts, generate continual improvement, and preserve regulatory compliance While using the rules.
Style and design critique is usually a well-founded GMP consultancy assistance. By this treatment planned or currently built technological equipment and installations are approved on quality by design and style requirements, suitability and GMP compliance.
Providers Providers EY allows purchasers build long-expression benefit for all stakeholders. Enabled by data and technological know-how, our providers and methods provide have faith in by assurance and support clientele renovate, mature and work. Technique by EY-Parthenon
Tips on how to layout an air handling system Conference the requirements of space cleanliness classification and environmental protection?
Our benefits-driven group will write and put into practice your GMP method, prepare you and stick with you right until you pass your GMP certification audit.
We realize get more info the complexities of working a lifetime check here science business enterprise and have areas of expertise that include each facet of R&D, functions, regulatory affairs, good quality, and manufacturing.
- Becoming a member of our IGAP application/ Audit report library is free for suppliers/manufacture. Our knowledgeable and competent auditor will conduct whole site audit of provider covering large range of molecules/goods (Otherwise by now carried out) without having demand to supplier and specific audit report shall be organized.
A GMP marketing consultant delivers the qualified assistance essential to navigate the complexities of GMP compliance. Their intensive understanding of area and Worldwide restrictions, market greatest techniques, and the most recent updates in the sphere equips your organization Using the tools to meet and exceed regulatory standards.
We'll generate your provider approval method, do the job together with you to put into practice it, and teach you to maintain it functioning.