1. Clinical Research Services VLL/CR/G20/ 2009/09/30

2.  Clinical Research Services  About VIMTA Labs  Why VIMTA?

3. Services Bioavailability/Bioequivalence studies Clinical end point studies Phase I-IV trials of drugs and medical devices Bioanalytical Services Safety and efficacy studies on cosmetics

4. Full Service CRO for BA/ BE Studies Regulatory services Medical Writing ICF Design & implementation in regional languages. IEC (IRB) Approval Volunteer recruitment & Clinical screening Clinical conduct PK Analysis Stats & Report Writing Adverse Event Reporting Long term archival

5. Clinical Study Experience Bioavailability/Bioequivalence studies on various dosage forms: Tablets, capsules, film strips, gels, jellies, oral solutions, dermal patches under several study designs Single dose, cross over studies Single dose, replicate design studies Multiple dose, steady state design studies Parallel design studies Clinical end point studies: Gastrointestinal Safety and efficacy studies on cosmetics: Deodarants, Industrial Hand Wash products, Shampoos, etc. Total No. of clinical studies completed so far: 1000+

6. BA / BE Studies Bio-availability/Bio-equivalence studies conducted since 1994 Volunteer database of 20,000 healthy volunteers, including female volunteers 200 bed clinic capacity Fully equipped ICU (8 beds) Bioanalytical lab, with 11 mass specs, dedicated to BE studies - operates round the clock In-house Clinical Lab, that is among the most sophisticated in India

7. Bioanalytical Services - Capabilities Vimta provides bioanalytical services to support the following types of studies Early phase clinical trials: Bioavailability/ Bioequivalence studies Food-interaction studies Drug-drug interaction studies Dose finding studies Pre-clinical TK studies ADME studies

8. Experience & Infrastructure Total number of validations completed: ~300 Compound specific validations completed: ~200 A pool of 27 Mass Spectrometers (LC MS and GC MS) across 2 Sites in Hyderabad Average number of samples analyzed per annum: 0.5 million 13 Deep Freezers (four -20’s, two -20 walk-in-chamber and 7 -70’s)

9. Notable Achievements FDA Submissions: Provided bioanalytical support for more than 100 ANDA filings, few INDs and NDAs FTE model: Provided bioanalytical services to a large American pharma company under FTE model, that resulted in a rate as low as $19 per sample Developed capabilities in a diverse set of analytical methodologies for PK analysis – such as LC MS, GC MS, ICP MS, RIA, etc.

10. Capabilities for Studies in Patient Population Site Management and Study Monitoring services for Phase II-IV trials PK studies in patients Clinical end point studies

11. Site Management Services Investigator (& site personnel) support Site Support Study Conduct  Facilitate Initiation, Monitoring, Close-out,  Close coordination with Sponsors and CROs &  Site preparation for Audit Study Process Management

12. Vimta Site Management Services: for Investigators On-site training programs to PI and study team Trained and experienced clinical research coordinators placed on site Protocol analysis Budget negotiations with Sponsor Implementing proven patient recruitment strategies Independent protocol audits by QA team Preparation for external Audit (sponsor/FDA/Third party)

13. Vimta Site Management Services: for Clinical sites (Hospitals) Site set up & Conduct of Clinical Trials IRB/ EC set up & members’ training Site specific & EC WPDs & SOP’s GCP and protocol training (to Site Staff) Onsite Pharmacy set up Trained and experienced clinical research coordinators placed on site Drug Safety Services Training

14. Vimta Site Management Services: for Study Processes  Patient- Recruitment, Informed Consent, Investigations, admissions (if inpatient), follow-ups (if outpatient), compensation, information & queries;  Study Drugs or Devices management including Randomization & IVRS, cold/ temperature controlled storage, drug/ device dispensation logs & accountability;  Documents management including but not limited to Informed Consent Documents & their translations / back translations; CRF entries & Query generation; Diary card preparation & its training; Site master files; Study logs; Clinical trial reports;  Regulatory including a] Ethics committee correspondence, approvals and query management, b] DSMB coordination

15. Collaborations Vimta is now associated with multiple Indian hospital sites. Overall 20 sites to collaborate. 7 Sites signed MOUs for CCEs exclusively with Vimta. Spread across TAs-2 teaching hospitals/medical universities; TA Specific- 1 Neuropsychiatry, 1 Derma & 1 oncology. Sites chosen based on clinical care & clinical research capabilities. Predominantly near South India: better logistics& cost control. Hyderabad New Delhi Chennai Vishakapatnam Rajamhundry Coimbatore Madurai Mumbai Lucknow West Bengal Bangalore

16. Clinical Trial Operations Medical Affairs Clinical Quality Control (& Independent Quality Assurance) Project Management Regulatory Liaison & Consulting Clinical Data Management & Biometrics Study Monitoring Services

17. Education profile: M.D, M.B.B.S, Ph.D, M. Pharmacy; Team Composition: Project Managers, Group Leaders, Scientists, CRAs, CTAs Experience profile:  PM ~ 5-7 years: M.Pharm, Ph.D  GL & Above~ 1-4 years: M.B.B.S, M.D, Ph.D  Scientists & CRA ~ 1-2 years: M.Pharm, M.Sc Main Functions:  Site Initiation, Monitoring, Close-out, Project Management - Experienced CRAs & PMs  Coordinating Site Audits- With External Auditors  Medical Monitoring-Qualified & Trained (CR) Clinicians/ Consultants available Study Monitoring Services: Clinical Operations

18. Site Monitoring Services: Medical Affairs Education profile: M.D, M.B.B.S, M.Pharm, M.Sc Team Composition:  Medical Monitors & Reviewers- M.D / M.B.B.S with Experience  Safety Associates: M.B.B.S / M.Pharm / M.Sc with Experience;  Clinical Associates- M.B.B.S / M.Pharm / M.Sc with Experience  Medical Writers- M.D/M.B.B.S / M.Pharm with Experience Functions:  Investigator/ Site Pre-Qualification, Selection & Feasibility – Feasibilities<1-2 Wks;  Trial Documents’ Preparation- Protocols & Reports;  Support to Clinical Operations for Medical Monitoring & Drug Safety;

19. Notable Achievements FDA Submissions: Provided bioanalytical support for more than 100 ANDA filings, few INDs and NDAs FTE model: Provided bioanalytical services to a large American pharma company under FTE model, that resulted in a rate as low as $19 per sample Developed capabilities in a diverse set of analytical methodologies for PK analysis – such as LC MS, GC MS, ICP MS, RIA, etc.

20. Summary of Regulatory Submissions Regulatory Agency Study reports submitted Studies conducted since year of 1st inspection No. of pivotal studies conducted so far US-FDA BE studies, TK studies, Phase-I trials 20022005> 200 WHOBE studies20002004> 15 EUBE studies20012005> 20 DCGI (India)BE studies1994N/A>300 Others (Health Canada, TGA, MCC, etc.)BE studies2000N/A>20

21.  Clinical Research Services  About VIMTA Labs  Why VIMTA?

22. Service Offerings Bio-analytical Analytical Pre-Clinical Clinical Ref. LabClinical Research Environmental Adv. Mol. Bio. R & D VIMTA

23. Recognitions & Accreditations  Accreditations ISO 15189 and ISO 17025 by National Accreditation Board for Testing & Calibration Laboratories (NABL), India  Regulatory Audit History US FDA (Ref. ICH GCP and GLP) – 4 inspections DRAs of Sweden, Denmark, & Portugal (Ref. ICH GCP and GLP) BfArM Germany (Ref. ICH GLP) WHO (Ref. ICH GCP and GLP) – 4 inspections Anvisa, Brazil (certification due for renewal) Pre-qualified by WHO for cGMP compliance

24. IT Infrastructure Hardware: IBM i550 server (Consists 12 Logical Servers) IBM DS 6800 (Capacity 15 TB expandable to 62 TB) First 10 G Passive Network in the Asia Pacific Region Cisco 6513 Integrated Services Router Software: Labware LIMS Waters SDMS (Scientific Data Management System) SAS and WinNonLin Lotus DomDoc (for Document Management)

25. Staff Scientific staff - 442 Undergraduates – 125 Masters – 274 Doctorates (Ph.D.) – 22 Clinicians (MBBS/MDs) – 21 Supporting staff – 265 Total – 707

26.  Clinical Research Services  About VIMTA Labs  Why VIMTA?

27. Why VIMTA? Independence: Truly independent CRO, not affiliated to any pharmaceutical or other drug development company, or any other organization Good Governance: Being first CRO to be listed national stock exchanges of India, we operate in an ethical and transparent manner Financial stability: 25 years of track record in sustained growth Strong balance sheet Ability to fund massive investments: invested ~$30 M during the last three years in capacity building Credibility & Strong Project Management Skills: Long term partnerships built with many industry leaders across the globe

28. Thank you