Klassen Consulting, LLC
Services
Project & Crisis Management
- Quality Assurance/Quality Systems
- Quality Control
- Regulatory Affairs CMC
- Regulatory Compliance
- Regulatory Action Remediation
Regulatory Consultation & Technical Writing
- Chemistry, Manufacturing, and Controls (CMC) section of
- Investigational New Drug Application (IND)
- New Drug Application (NDA)
- Biologics License Application (BLA)
- Drug Master File (DMF) development, amendments and annual updates
- Post-Approval Change (PAC) supplements to NDA, ANDA, or BLAs
- US Agent to Foreign API and Drug/Biotech/Biological Product Manufacturers/Suppliers
- Regulatory and CMC related sections of Briefing Packages for FDA Meetings
Regulatory Compliance
- GMP Audits (Supplier, Manufacturer, Distributor)
- Regulatory Action Remediation (483s, Warning Letters, Consent Decrees)
Training
- Regulatory Authority Inspections
- Meetings with Regulatory Authorities
- Good Manufacturing Practice (GMP) regulations