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Medication

Drugs & Biologics

A drug is defined as any substance (excluding food and water) that, when inhaled, injected, smoked, consumed, absorbed through a skin patch, or dissolved under the tongue, induces a physiological change in the body. Drugs may be synthesized through chemical reactions or semi-synthesized from biological sources, the latter being classified as biologics.

CFR Compliance LLC™ is committed to ensuring patient safety and drug efficacy through a culture of science and compliance. We support clients in various stages of drug development, including early development, clinical operations, regulatory submissions, and process engineering. Additionally, we ensure that commercial operations comply with FDA regulations and other agency requirements related to prescription practices and healthcare professional interactions. Our experienced team assists with compliance for US FDA, OIG, EMA, FTC, US Customs, ICH, and international Ministries of Health. Some of our services include:

 

Regulatory Affairs

  • Regulatory Strategy

  • Investigational New Drugs (INDs)

  • New Drug Application (NDA)

  • Biological License application (BLA)

  • Abbreviated New Drug Application (ANDA)

  • Annual Product Review and Annual Reports

  • Type A, B, C Meetings

  • Orphan Drugs

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Good Clinical Practices - GCP

  • Clinical QA and GCP Systems Implementation

  • Clinical Operations Support for Site Initiation, and Enrollment

  • Onsite Clinical Monitoring

  • HIPAA Compliance 

  • Clinical QA Audits

  • IRB participation and auditing

  • GCP Training for Sponsors, PIs and CROs

 

Good Laboratory Practices - GLP

  • PreClinical QA and GLP operational support

  • NonGLP and GLP QA Systems Implementation

  • Study Protocol Drafting 

  • Test Article, Vivarium, Necropsy, Histology Auditing 

  • GLP Training 

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Good Manufacturing Practices - GMP

  • Fractional Quality Management Services

  • Remediation for Form 483, Warning Letter and Consent Decree

  • CMC and drug specification development

  • PreApproval Inspections (PAIs)

  • Process/Product Transfer and Engineering

  • Process Validations

  • Supplier Quality Management and Auditing

  • GMP Inspection support

  • GMP Training

Need more details?  We are here to assist. 
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