DOCUMENTATION
 
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- Drugs: NDA, IND, ANDA, & supplements
- Medical devices: 510(k) & PMA
- Response to form FDA483 "Inspectional Observations"
- 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
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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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