Our Expertise
In more than 75 non-clinical and 170 clinical trials, QST has developed significant expertise in a variety of fields. 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 dozens of approved submissions.
| | PMA | NDA | 510(k) | ANDA | OTC | TOTAL |
|---|
| Dermatology | | 19 | | 7 | | 26 |
| Ophthalmology | 15 | | | | | 15 |
| Allergy/Asthma | 1 | 1 | 1 | 1 | | 4 |
| Cardiovascular | 1 | | 2 | | | 3 |
| Diagnostic Systems | 1 | 1 | 1 | | | 3 |
| Pain Management | | 2 | | | 1 | 3 |
| Pregnancy Facilitation or Prevention-Related Devices | 1 | | 2 | | | 3 |
| Pulmonary | 1 | | 1 | | | 2 |
| Surgical LASER Systems and Cosmetic Devices | | | 3 | | | 3 |
| Antifungals | | | | 1 | | 1 |
| Hair Growth | | | | | 1 | 1 |
| Nasal Dilator | | | 1 | | | 1 |
| Obesity | | | 1 | | | 1 |
| Post-Herpetic Neuralgia | | 1 | | | | 1 |
| TOTAL | 20 | 24 | 12 | 9 | 2 | 67 |