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We aid A huge number of companies, together with 17 of the very best 25 world pharmaceutical, biotech, and clinical machine firms, link With all the experts they have to have through the optimal workforce design.
Hence, all provider qualification steps contribute to the overall ambitions of medicinal product or service safety, performance and compliance.
“We realized if we wished to get wherever we needed to go along with our small business and securing a number of These big shoppers, that we required to have SQF certification. After i very first commenced speaking with Kellerman Consulting, I knew they have been industry experts.
The definition with the scope being analyzed could be the duty with the consumer. In case of in depth gap analyses, the GMP/GxP expert doing the Evaluation might advocate clarification of interfaces or transitions among specific analyses.
Choosing a GMP specialist is a important selection which will form your compliance journey and impact the general good results of your online business.
Alex has held administration amount roles in Quality Assurance, making sure solution quality & regulatory compliance, together with Senior Specialized Supervisor positions liable for CMO management, oversight and tech-transfer of pharmaceutical goods. This knowledge equips him nicely in evaluating production methods for early stage items, as well as late period and professional items for EU and US marketplaces.
Kellerman Consulting has supported countless consumers nationwide to efficiently pass their regulatory inspections as well as their GMP and cGMP certification audits.
All GMP consultancy through your totally free GMP session, you’ll study what the necessities are for obtaining Accredited, the amount it expenditures with no hidden charges, just how long it requires, And just how our process will work to guarantee you pass your GMP certification audit on the very first try out.
Laura with Kellerman Consulting is just fantastic. She is rather beneficial, easy to work with and acquired us as a result of our GMP audit that has a far better score than we expected. Also, the organization of every one of the paperwork Kellerman Consulting provided us with is great.
It leads to improved current market pace and increased transparency and accountability throughout many corporations associated with formulation (throughout check here many dosage types), API and biosimilar.
As your associates, Regulatory Compliance Associates can negotiate the possible minefield of regulatory compliance and regulatory homework with insight, hindsight, as well as apparent advantage of our one of a kind experience and experience.
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