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DOCUMENTATION

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  • Drugs: NDA, IND, ANDA, & supplements
  • Drug Master File (DMF)
  • Medical devices: 510(k) & PMA
  • Response to form FDA483 "Inspectional Observations"
  • Process validation
  • Freedom of Information (FOI) Act inquiries
  • Over-the-Counter (OTC) drug review comments and submissions
  • Material Safety Data Sheets (MSDSs) for OSHA hazard communication
  • EPA and state permit applications: air, water, hazardous waste

o Right-to-Know reporting

o Standard Operating Procedures (SOPs) for manufacturing and Current Good Manufacturing Practice (CGMP) compliance

o CPSC Poison Prevention Packaging (PPP) Act exemption petitions

 

REVIEW

o Raw materials o Advertising
o Labeling o Finished products
o Operations o Training

 

COMPLIANCE AUDITING

o Plant o Laboratories
o Warehouse o Paperwork

 

AGENCIES

o Food and Drug Administration (FDA)

o Environmental Protection Agency (EPA)

o Occupational Safety and Health Administration (OSHA)

o Consumer Product Safety Commission (CPSC)

o Federal Trade Commission (FTC)

o Department of Transportation (DOT)

o States: NJ, NY, PA, CA, FL

 

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