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Experts in FDA Compliance

Click below to view resumes of KKAI's top experts in this field. They are the most experienced, the most knowledgeable, the most respected - and they are ready to begin solving your challenge today. Whether that means securing the help of one world-class expert or assembling a team of them, KKAI can do both on a rapid-response basis anywhere in the world.

Experts in FDA Compliance
Resume of QCI Biochemist, Scientist, FDA Regulatory Compliance Consultant, Expert, biotechnology, healthcare industry, clinical trials, FDA GCP regulations, and R&D direction, FDA regulations for IVDs and pharmaceuticals, risk and hazard analysis, FDA compliance regulations, diagnostic medicine, cancer research, immunoassay development
Resume of CHL Chemist, Biotechnology Consultant, Product and Process Validation Consultant, Expert, process validation audits, FDA compliance, analytical instrument validation, generic solid dosage manufacturing
Resume of ZEV Biochemist, Quality Assurance Expert, Validation, Manufacturing and Packaging Specialist, QA cGMP Compliance Consultant, Expert, QA cGMP compliance background in Title 21 CFR §58, 210, 211, 600, and 820; FDA QSIT, ISO 13485, direct interaction with the FDA and third parties; process validation; preparation of manufacturing and packaging records
Resume of YRL Biochemist, Pharmaceutical Quality Assurance Consultant, Physical Organic Chemist, Validation Study Consultant, Expert, specializes in form FDA 483 and warning letter responses, corrective and preventive action plans, training, general cGMP, general validation, and test method validation, negotiations with regulatory agencies
Resume of TNH Microbiologist, Production Manager, Consultant, Expert, FDA, USDA, EPA, food safety, food security and Kosher regulations, total quality management and SPC, product and packaging material sensory analysis, food safety, and manufacturing processes

 

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For additional or different expertise, browse other top-level expert resumes from our broad offering of Failure Analysis, Manufacturing Optimization and a host of other Engineering and Scientific Consulting services.

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  • We work exclusively with experienced, senior-level, top-of-their-field experts who are committed to the highest standards of quality and professionalism.
  • Our Lead Consultants and 475-plus experts work on a rapid-response basis to ensure deliverables are completed accurately, on time and within budget - every time.
  • When you call KKAI, a veteran Lead Consultant will immediately begin working to resolve your critically important issue. Whether that means deploying one expert or a dedicated team of experts, we are uniquely positioned to deliver both instantly.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax


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