Experience

QST Consultations has extensive experience providing statistical support services to the medical research industry. In over 75 non-clinical and 170 clinical trials, our knowledge spans such areas as food consumption, body weight/gain, clinical pathology, hematology, clinical chemistry, urinalysis, organ and percent organ weight, pharmacokinetics, and reproduction/teratology. In addition to providing support for our clients in face-to-face meetings with the FDA, we have developed significant therapeutic expertise in several key areas that include wide-ranging support for 54 approved submissions:

• Dermatology (15 NDAs and 5 ANDAs)
• Ophthalmology (15 PMAs)
• Allergy/Asthma (1 NDA, 1 510[k], 1 ANDA)
• Cardiovascular (2 PMAs)
• Pregnancy Facilitation or Prevention-Related Devices (2 510[k]s)
• Pulmonary (1 PMA, 1 510[k])
• Pain Management (1 OTC, 1 NDA)
• Surgical LASER Systems and Cosmetic Devices (2 510[k]s)
• Diagnostic Systems (1 PMA, 1 510[k])
• Obesity (1 510[k])
• Post-Herpetic Neuralgia (1 NDA)
• Hair Growth (1 OTC)
• Antifungals (1 ANDA)