Bioequivalence studies have become an essential requirement for registering new pharmaceutical products in markets across the world. We conduct ethical bioequivalence studies which are cost-effective, while offering a very rapid turnaround time.
Please fill your contact details in the quick query form so that one of our experts can contact you to discuss your requirements and assist you with the further direction to be taken for trouble-free registration of your products.
We don’t only conduct bioequivalence studies, but can also guide you on the requirements for various markets and also help you solve queries from regulators on your existing product applications and if there are any queries on studies conducted by us.
Auriga Research Ltd (ARL) is Conceptualized as an organization fulfilling the ardent need of clients by offering fully integrated service package to pharmaceutical, medical device and biotech industry. Services include bioequivalence studies, Clinical Trial services (Phase I to IV), formulation development, analytical method development & validation and Regulatory compliance services etc. Auriga’s Bioequivalence facility is approved by DCGI having rich experience of conducting more than 50 BA/BE studies for different regulatory bodies.
The company’s CPP unit has a 30 bedded facility, designed to provide subjects the utmost safety, hygiene and comforts while offering a systematic flow for conduct of BA and BE studies. ARL also has a fully equipped ICU service to handle potential emergencies. Access controlled Pharmacy & archival area of ARL ensures safe custody of documents and IP. Healthy volunteer’s database availlable with ARL comprises of both male and female volunteers. Strict adherence to GCP & Schedule Y is practiced in overall conduct of all the studies undertaken by ARL and team has experience of conduting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc.
ARL with its advanced analytical infrastructure to support pharma industry offers following services:
- Comparative BA/BE studies
- Fasting/Food effect studies
- Special Population Studies
- Interaction studies
- Multiple dose and steady state studies
Bio analytical facility of ARL is accredited with NABL with globally accepted system and SOPs. Bioanalytical department is equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc and having more than 60 validted methods as per US-FDA guideline.
ARL also offers regulatory services, which include new drug application, NOC from DCGI, Import License, and Sourcing of Innovator etc. Our statistical analysis pacakage include Staistical Analysis Plan, PK analysis, Sample size calculation by our expert biometrician using SAS and WinNonLin.