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Medication

Drugs & Biologics

A drug is any substance (except food and water) that, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body. Drugs can either be synthesized by chemistry reaction, or semi-synthesized from biological sources, which in that case are known as biologics.

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CFR Compliance LLC™ believes that patient safety and drug efficacy must be supported by a culture of science and compliance. We assist clients in early drug development, clinical operations, regulatory submissions and process engineering. We also provide services to assure that commercial operations are always compliant to FDA and other agency requirements affecting prescription and HCP interaction. Our highly qualified staff will assist with each requirement established by US FDA, OIG, EMA, FTC, US Customs, ICH, and international Ministries of Health. Some of our services:

 

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

  • Remediation for Form 483, Warning Letter and Consent Decree

  • CMC and drug specification development

  • PreApproval Inspections (PAIs)

  • Process/Product Transfer and Engineering

  • Process Validations

  • Supply Chain and US Customs Compliance

  • GMP Inspection support

  • GMP Training

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