CFR Compliance LLC
Compliance, Regulatory & Quality Professionals
Compounding Pharmacies
Similar to drug companies, compounding pharmacies specialize in manufacturing substances (excluding food and water) that, when inhaled, injected, smoked, consumed, absorbed through a skin patch, or dissolved under the tongue, induce a physiological change in the body.
CFR Compliance LLC™ is dedicated to ensuring patient safety and drug efficacy through a robust culture of science and compliance. We offer services to ensure that commercial operations consistently adhere to FDA regulations and other agency requirements related to prescription practices and healthcare professional interactions. Some of our services include:
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Fractional Quality Management 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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Process/Product Transfer and Engineering
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Process Validations
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Supplier Quality Management and Auditing
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GMP Inspection support
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GMP Training