Compliance Remediation & Quality Systems Implementation
PharmaLogika consults with pharmaceutical, biotech, and medical device quality units to provide third party audits, pre audit inspections (PAIs), compliance remediation, and a portfolio of related quality and regulatory affairs products and services. Regulatory action guidance as well as quality systems guidance are delivered as part of our standard products and services. Through the use of highly skilled resources throughout the process, each offering is designed to enact a comprehensive quality systems approach in addressing Quality Assurance (QA) issues. The results insure a close adherence to current Good Manufacturing Practice (cGMP) standards.
Remediation services are offered in response to communications (Form 483 observations, warning letters, and consent decrees) received from the United States Food and Drug Administration (FDA). Any legal action followed by an FDA inspection can be the result of a safety, quality, identity, potency, or purity (SQuIPP) deficiency for pharmaceuticals (21 CFR 210 - 211) and biologics (21 CFR 600). We conduct compliance upgrades for manufacturing, packing, storage, or installation process nonconformity with CGMP requirements of the Quality System (QS) regulations for medical devices found within Title 21 of the U.S. Code of Federal Regulations (21 CFR 820). We assist companies in reestablishing their regulatory compliance for adulterated products that are intended to affect the structure or function of the body, medical devices, or foods and dietary or nutritional supplements.