Klassen Consulting, LLC has extensive regulatory experience with more than 550 projects including IND, NDA, BLA, DMF applications, supplements, amendments and annual reports.
We have extensive regulatory compliance experience with more than 16,000 hours in regulatory authority inspections involving domestic and foreign regulatory agencies.
We have extensive project and crisis management experience with regulatory action remediation for 483, warning letter, and consent decree situations.
We also have conducted more than 800 manufacturing, laboratory, and supplier cGMP audits in the US and 16 foreign Countries. Finally, we have extensive quality assurance experience in the development, implementation, and conduct of quality systems.
Experience by Therapeutic Indication:
Acute Bacterial Sinusitis
Iron Replacement Therapy
Cerebral Vascular Incident
Amyotrophic Lateral Sclerosis
Oral Mucositis due to Chemotherapy
Biotech & Biosimilars (Proteins, Peptides, Monoclonals, Recombinants)
- Anthrax (Bacillus anthracis) Vaccine
- Plague (Yersinia pestis) Vaccine
- Allergic Rhinitis
- Ulcerative Colitis
- Rheumatoid Arthritis
- Spasmodic Torticollis
- Growth Hormone Deficiency
- Blood Related Disorders
- Blood Volume Deficiency
- Hemophilia B (Factor IX Deficiency)
- Immune Thrombocytopenic Purpura
- Primary Humoral Immunodeficiency
- Alpha-1-Proteinase Inhibitor Deficiency
- Hemolytic Disease of the Newborn (HDNB)
- Hemophilia A (Hemophilic Factor VIII Deficiency)
Drug/Biological-Device Combination Products
- Anaphylaxis (Auto-injectors)
- Antibacterial agents (Applicators)