Irrespective of whether you’re in the product setting up, progress or pharmaceutical lifecycle management stage or need a remediation strategy for the compliance crisis, Regulatory Compliance Associates will manual you thru each and every pharmaceutical consulting phase of your regulatory process.
Gap Assessment is really a classical consulting Instrument to align The existing Using the target standing. It relates possibly to your complete GMP program of a controlled company or to particular person subareas.
Customized companies for every program, with customized procedures intended to meet up with extremely particular wants. We’ve acquired a great deal about what is effective and what doesn’t. Look through the most recent learnings and insights from our scientific improvement specialists.
By means of many years of connecting scientific operations professionals with prospects worldwide, we’ve made a substantial Energetic, and extended pool of proficient pros.
“We understood if we desired to get wherever we wanted to select our business and securing several of Individuals significant prospects, that we needed to have SQF certification. After i to start with commenced talking to Kellerman Consulting, I understood they ended up professionals.
Unparalleled experience: Our consultants have broad sector working experience and an insider’s point of view from their time as GMP inspectors. They have got stood on either side of the GMP compliance equation, delivering them with a novel knowing that informs each and every support we offer.
Commissioning, Qualification & Validation We do the job with our clientele to develop scalable resource options to help validation endeavours all over the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our means have you covered.
Legislation corporations searching for pharmaceutical consulting business knowledge while in the remediation of warning letters, consent decrees, 483’s or import bans
Experienced dozens of pharmaceutical executives and leaders on how to correctly and compliantly use The brand new digital Device to streamline workflows and critical procedures
Make sure the quality of your products and solutions by creating a QMS. Valicare's industry experts will assistance you with QM consulting, document preparation & implementation.
ADAMAS’s Great Manufacturing Apply (GMP) gurus can do the job To judge systems at your pharmaceutical, biotechnology, or health-related system Group or at your vendor web pages to ascertain If your techniques in place are adequate click here to satisfy your production demands and The existing regulatory criteria.
We've done more than seven-hundred+ Vendor/Provider Qualification audits. Regionally based mostly consultants in broader geography so productive high-quality of labor read more with out language barrier and travel restrictions.
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In case you’re an formidable get started-up, a disruptive entrepreneur, a next era chief of the relatives business or a transformative CEO, we can assist you achieve your development ambitions and produce a legacy for being pleased with.