BA/BE Studies conducted at MTRL are in strict compliance with International Regulatory Requirements, monitored by an independent quality assurance department.
We have active volunteer database of over 32000 volunteers, including healthy volunteers, special populations and female volunteers.
We have completed more than 1700 BA/BE Studies and successfully cleared USFDA Audit with NIL 483.
MTRL has a dedicated volunteer mobilization team which does the mobilization of the volunteers to accelerate the completion of study in time.
MTRL can undertake the following studies :
- Single & multiple dose studies.
- Fasting & Fed condition studies.
- Drug-Drug Interaction (DDI).
- Pharmacokinetic interaction studies.
- Pharmacodynamic Studies.
- Food Effect studies.
- Cross over and parallel studies.
- Replicate studies.
- Proof of concept studies.
- Special population studies (postmenopausal & adult female studies and geriatric studies).
- Studies comparing routes of administration.
- Studies comparing immediate and modified release forms.
MTRL has the capability to conduct studies for various routes of delivery and formulations like:
- Oral Dosage Forms
- Tablets and Capsules
- IV, IM, SC
- Transdermal Patches
- Nasal Sprays
- Ointments & Creams