We are excited to share with you that our Bioequivalence (BE) center has been approved by NPCB (National Pharmaceutical Control Bureau), Ministry of Health Malaysia.
We are one of only five BE centers in India having approval from NPCB, Malaysia. Here is the link of their website with details of approval.
As Malaysia is part of PIC/S group of countries so a BE study conducted by us can now be submitted in PIC/S countries. Here is link for countries part of PIC/S (Pharmaceutical Inspection Co-operation Scheme).
Our BE center is approved by CDSCO, India since 2007 and we have completed more than 80 BE studies for submission to ROW and CIS countries. Our CPP unit has a 30 bedded facility, which is designed to provide subjects the utmost safety, hygiene and comfort while offering a systematic flow for conduct of BA and BE studies.
We have a fully equipped ICU for handling potential emergencies, access controlled archive area for archival of documentation, biometric for volunteers participation and pharmacy area for investigational product and we present study protocols to a Sch Y and ICH GCP compliant Ethics Committee.
Our team has experience of conducting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc.
Our Bioanalytical facility is also accredited from 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 validated methods as per US-FDA guideline.
With our regulatory support services which include new drug application, NOC from DCGI, Import License, and Sourcing of Innovator we are a full service CRO for bioavailability and bioequivalence studies.
With fully integrated service package for BE studies-Commitment lies with
- Highest quality clinical services meeting strict ethical norms
- Successful bio-analytical method development and validation of even industry-challenging molecules,
- Professional data management executed through validated processes and reporting services.
- Clinical facility includes spacious subject housing units, segregated counseling and screening areas, fully equipped round the clock ICU, canteen and recreational area, closely monitored and frequently audited kitchen with approved meal plans from dietician.
- Complete confidentiality to our sponsors’ businesses and to our volunteer database.
- Bioavailability / Bioequivalence Studies carried out for of all therapeutic categories & classes of subjects, using in house SOPs developed as per ICH-GCP Guidelines,ICH E3 guideline for bioequivalence report preparation.
- PK data analysis is done by latest version of PK software (WinNonlin 5.2) and final data is evaluated by renowned consultant Bio-statistician.
Path Lab/Diagnostics Services
Central lab services from NABL/CAP accredited labs.
Services with alliance /partner organization.
We also offer Phase I –IV Trials & Data Management services with the collaboration of our partners.
Our clinical team includes Principal investigator, Clinical Investigator, Project Manager, Medical officer Clinical Research Associate, Pharmacist, Medical Writer, Phlebotomist, Staff Nurse, Volunteer development officer, Consultant Biostatistician and Independent Quality Assurance team .
Range of BA-BE service
Auriga Research Limited conducts BA & BE studies for pharmaceutical formulations and for regulatory submission. This includes BE studies intended for submission in ANDA & BE studies conducted in the post approval period for certain changes in both NDA & ANDA.
In BA-BE Centre ARL conducts following types of studies
- Bioavailability/Bioequivalence Studies
- Relative bioavailability of established and experimental formulations
- Single and multiple-dose (Steady state) kinetic studies
- Fasting / Food-effect kinetic studies
- Drug interaction studies
- Studies comparing Immediate and modified release formulations
- Pharmcodynamic studies
- Studies comparing various Routes of Administration
- Studies in Healthy Volunteers / Special Population
Some of the highlights of functioning at BA/BE Centre are:
- Blood and urine sampling for screening
- Dedicated Blood withdrawal area for study samples
- Matrix separation with refrigerated centrifuge
- Dining area and recreation area
- Change room with lockers for volunteers
- Report writing and documentation cell
- Documentation archival room
- A team of highly experienced and motivated professional
- Standard Operating Procedures to comply with ICH-GCP and other international guidelines
- Independent Ethics Committee
- Extensive database of Volunteers (including special population)
- Audited catering services on annual contract with a well qualified Dietician
- Translator on contract for conversion of ICD in vernacular / Hindi language
- Fire drills and patient evacuation drills on regular basis