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Quality Systems / QA/QC / Validations

Risk assessment and auditing of Quality Management systems, including QC/QA.

Griffin-Gamma LLC., consults in areas of Quality Systems Recovery/Development, Drug Design, Product Quality Assurance/Control, and Safety (FDA Drug Regulations 21 CFR 210, 211 and Device Regulation 820, and ISO Medical Device Standards 13485:2016, EU Regulations, TGA, Health Canada, Japan’s PMDA).
 
Griffin-Gamma LLC., assists companies with failed quality, regulatory, and operational/processing systems to become compliant under FDA 21CFR Parts 210, 211, 820 and also assists these companies to maintain clean records without damaging observations or 483s  during follow-up FDA Audits.

Authoring of global/corporate standard operating procedure (SOPs) for the pharmaceutical, cosmetic, and device plants.


Establishing preparatory programs for client quality and regulatory audits. Griffin-Gamma LLC., assists companies in developing of Standard Operating Procedures, Training and Compliance, Quality Audits and Inspections of pharmaceutical, cosmetic and medical device facilities.

Pharmaceutical / Medical Device / Skincare / Cosmetic


Product and Process development and scale-up of pharmaceutical/medical products; Validation of manufacturing and production processes; Acquisition of pharmaceutical, cosmetic, and medical equipment.

Griffin-Gamma LLC., also assists companies to gain ISO 13485:2016, Health Canada, Australia's TGA certifications, and many other regulatory and international registrations.
 
Griffin-Gamma LLC., assists companies in developing of Standard Operating Procedures, Training and Compliance, Quality Audits and Inspections of pharmaceutical, cosmetic and medical device facilities.