Style and design trials with enriched patient populations and change individual recruitment requirements to improve precision and velocity
“We partnered with Kellerman Consulting very early on within the SQF certification process, and by depending on their know-how and methodical method of accumulating, compiling, and organizing the required documentation, we ended up thriving in attaining our certification.
GMP consultants with QA experience understand how Each individual department inside the Corporation interacts Together with the producing processes and techniques. QA gurus have a whole image in your mind when designing an outstanding administration system and therefore are incredibly professional in federal, community, and Experienced expectations.
Regulatory Compliance Associates pharma regulatory consultants will produce an extensive evidence e book of documented proof demonstrating the corrective action taken to remediate non-compliant issues.
Qualification of premises, facilities and machines as well as the preparing of your corresponding documentation
Christina Sanchez Miller, MPH has in excess of 20 years of management, biologics, good quality assurance and study expertise inside the health care industry. She is a printed author in scientific publications, papers and has presented at various Global conferences.
Design evaluation is really a perfectly-recognized GMP consultancy company. By this technique prepared or by now created check here technological tools and installations are approved on high quality by layout conditions, suitability and GMP compliance.
This simple working experience, coupled with our comprehensive understanding of community and world regulations, positions us being an unmatched asset to any Group looking for GMP compliance.
With more than twenty years of experience with FDA, Overall health Canada, EU and international regulatory agencies around the globe, Regulatory Compliance Associates® features leading pharmaceutical consultants. We’re on the list of handful of pharma consulting firms which can help you navigate the worries affiliated with marketplace regulations.
This and the precise description of the necessities and processes allows the sufficient adaption of the resources to the actual need within your GMP procedure.
Laura with Kellerman Consulting is simply terrific. She is very useful, simple to operate with and bought us through our GMP audit having a a lot better score than we expected. Also, the organization of many of the documents Kellerman Consulting presented us with is superb.
- Signing up for our IGAP system/ Audit report library is totally free for suppliers/manufacture. Our knowledgeable and experienced auditor will accomplish whole internet GMP consultants site audit of supplier masking substantial range of molecules/merchandise (Otherwise previously performed) without charge to supplier and specific audit report shall be prepared.
It’s a pharma consultancy Established by regulatory compliance executives from the pharmaceutical marketplace. Each and every pharmaceutical industry specialist over the Regulatory Compliance Associates crew is familiar with the exceptional interior workings from the regulatory process.
Regulatory Compliance Associates Good quality consulting involves assessments, approach, implementations, team augmentations, and identification of good quality metrics to ensure steady improvement. Our pharma consultants realize the strategic imagining needed to align your organization wants and targets.