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As your partner, we are able to negotiate the potential evaluation minefield of regulatory compliance solutions with insight, hindsight, plus the apparent advantage of our breadth and depth of information and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs solutions for pharmaceutical companies.
We comprehend the complexities of managing a daily life science company and possess spots of experience that come with just about every aspect of R&D, functions, regulatory affairs, high-quality, and manufacturing.
Our pharmaceutical consulting Experts will produce a tailored method depending on your products and firm’s particular person needs. Our regulatory compliance shoppers contain:
Ongoing assistance: Our dedication on your Business doesn’t close While using the delivery of a consultation assistance. We have confidence in forging lasting partnerships, and as a result, we offer ongoing aid and coaching to ensure your very long-expression GMP compliance.
which were important to your prosperous completion of this process. I'd hugely recommend Kellerman Consulting for just about any of your consulting requires as they had been incredibly Expert and ensured that all objects had been dealt with previous to our audit. “
Alex has held administration degree roles in High-quality Assurance, making certain products high quality & regulatory compliance, and Senior Technical Supervisor positions responsible for CMO administration, oversight and tech-transfer of pharmaceutical products. This practical experience equips him very well in assessing producing units for early section items, together with late stage and industrial merchandise for EU and US marketplaces.
Worldwide perspective: Our operations span all over the world, which means we are well-versed pharma consultants within the complexities of international restrictions.
We help internet site for properly passing inspections and design submit-inspections remediation strategies to establish & enhance GMP compliance and retain acceptance to your merchandise with Pharmexpert's personalized and value-powerful programs for High-quality Administration for Pharmaceuticals, Bio-Pharma and MD.
No matter whether you’re within the merchandise planning, growth or pharmaceutical lifecycle administration phase or need a remediation method for any compliance crisis, Regulatory Compliance Associates will manual you through every single pharmaceutical consulting phase with the regulatory process.
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By mock inspections we’ll Check out that all is as it should be, and goal remediation as wanted.
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