CFR Compliance LLC
Compliance, Regulatory & Quality Consultants
Compounding Pharmacies
Similar to drug companies, the compounding pharmacies specialize in the manufacturing of substances (except food and water) which, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body.
CFR Compliance LLC™ believes that patient safety and drug efficacy must be supported by a culture of science and compliance. We provide services to assure that commercial operations are always compliant to FDA and other agency requirements affecting prescription and HCP interaction. Some of our services:
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Good Manufacturing Practices - GMP
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Remediation for Form 483, Warning Letter and Consent Decree
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CMC and drug specification development
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PreApproval Inspections (PAIs)
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Process/Product Transfer and Engineering
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Process Validations
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Supply Chain and US Customs Compliance
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GMP Inspection support
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GMP Training