Clinical Research Capabilities Bioavailability & Bioequivalence Studies Clinical Research Division

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2 Clinical Research Capabilities Bioavailability & Bioequivalence Studies Clinical Research Division

3 03 CLINICAL RESEARCH SERVICES

4 VIMTA STRENGTHS Experience 32 years of track record in supporting Pharma& Life Sciences industries A Truly Independent CRO Not affiliated to any Pharmaor Life Sciences organization Core Value Integrity of service through honesty, responsibility and uncompromising devotion to Quality Strong Regulatory Compliance Long standing experience in working as per different regulatory frameworks One-stop-shop for testing your generic pipeline knowledgeable, experienced, motivated and committed team Effective and Efficient Project Management 04

5 Bioavailability & Bioequivalence Studies 05

6 REGULATORY AUDIT EXPERIENCE REGULATOR NO. OF INSPECTIONS DCGI (India) 4 FDA (USA) 10 MHRA (UK) 2 BfArM (Germany) 2 ASNM (France) 2 WHO 4 DRAs of Denmark, Portugal & Sweden* MCC (South Africa) 2 ANVISA (Brazil) 2 NPCB (Malaysia)

7 BA/BE SERVICES Full service for BA/BE studies (1) In healthy volunteers & (2) In patients Study designing & protocol development Method development & validation Pre-study approvals for project initiation Project execution as per protocol and standard procedures Pre & post project regulatory support Statistical data analysis ectd submission Standalone services (Clinic/Bioanalytical/clinical Lab) 07

8 EXPERIENCE Study designing & protocol preparation Cross over, parallel, steady state, average bioequivalence (full/reference replicate designs) Testing of various dosage forms Tablets, capsules, orally disintegrating strips, gels, oral solutions, dermal patches and injectables Execution of studies with large sample size Over 350 validated bio-analytical methods 08

9 EXPERIENCE > 1700 BA/BE studies for customers across the globe Successfully contributed to more than 120 ANDAs and 505.B(2) applications in regulated markets Submissions to regulatory agencies: Regulatory Agency Studies conducted since No. of pivotal studies conducted so far DCGI (India) 1994 >400 USFDA 2000 >300 EU 2001 >50 WHO 2000 >15 Others (Health Canada, TGA, MCC, etc.) 2000 >50 09

10 IT POWERED PROCESSES Biometric solutions for identification of volunteers and cross participation status Audio-Video recording of consent process MedDRA for Adverse Event Coding Analyst software version for LCMS MS Mass Lynx version 4.1 for Micro Mass SAS version 9.2 Enterprise Guide 4.2 WinNonLin version 6.2 for PK analyses Electronic Document Management System SAP for Material Management 10

11 CLINIC 180 beds clinic capacity Healthy Volunteers Database In house volunteer screening facility In house clinical lab for safety assessments Fully equipped ICU to handle medical emergencies Synchronized clock systems (RF mesh network) Pharmacy for controlled storage of Investigational Products High volume centrifuges (temperature controlled)& freezers In-house catering facility to provide standardized food 11

12 CLINICAL LAB Dedicated automated biochemistry analyzers Back-up equipments to ensure continuity Testing for drugs of abuse Accreditations ISO/IEC by NABL (National Accreditation Board for Testing & Calibration Laboratories, India) College of American Pathologists (CAP) 12

13 BIOANALYTICAL Pool of 24 Mass spectrometers for rapid turnaround Different varients of LC MS MS(API 2000/3200/4000 & Micromass) LC MS MS 8050/8060 (for molecules with low sensitivity) GC MS MS(single & triple quadrapole) ICP MS for elemental analysis ELISA analyses for Iron preparations Dedicated equipment & scientists for each project Dedicated QC team for data verification Power backup for all equipments 13

14 SAMPLE STORAGE FACILITIES Cold storage, across 2 Sites in Hyderabad : Eleven Deep Freezers four (-) 20 0 C seven (-) 70 0 C (-) 20 0 C walk-in-chamber Long term data archival facility Dedicated storage facilities for clinical samples, bioanalytical samples, and clinical lab kits with central monitoring facility 14

15 Thank You For Your Time Vimta - CR Division 15