Beruflich Dokumente
Kultur Dokumente
CADILA CRO
V01/12/10
Our Objective: Taking life sciences to new horizons through innovative research, high quality, ethics & commitment.
Our Goal: To be a leading CRO in the world using committed resources & to achieve 100% quality and compliance with good science, accurate techniques, li ih d i h i prompt delivery and utmost Customer satisfaction.
V01/12/10
Pre-clinical and toxicology studies. Bio-availability / Bio-equivalence studies. Bio-analysis Clinical Trial Management :
Phase I Safety Studies Ph Phase II IV
Total Area 518 Sq.m with 8 Animal rooms & 1 Laboratory room. Double corridor facility. y Automated Illumination 12 hr. lighting in 24 hours cycle. 100% exhaust facility. No recirculation of air. Animal house walls painted with epoxy non-toxic washable paints. Species Propagated in-house breeding unit : NZW Rabbits, Wistar Rats, Guinea Pigs, Swiss Albino Mice, C57BL/6ByJ Mice, F1 C57 & DBA, DBA/2J Mice, BALB/C Mice
Accreditations : a. DSIR, Govt. of India. b. ISO 9001 and ISO 14001. c. Animal House is Registered With CPCSEA
V01/12/10
V01/12/10
V01/12/10
Capabilities p
Protocol development and Study designing. Conduct of a range of BA/ BE studies: Single dose /multiple dose ; Fasting /Fed / Steady state studies. Dose proportionality and Therapeutic equivalence studies. Th ti i l t di Open-labeled / blinded studies.
Successfully completed more than 209 studies which includes Intravenous Anesthetic BE study, studies, study Early phase exploratory vaccine trial, Drug interaction, female volunteers, and more.
V01/12/10 8
V01/12/10
Bio-Analytical Services
Features: Well equipped with latest detection methodologies. Instruments : LC-MS/MS, Automated HPLCs, UPLCs, Deep freezers, Refrigerated Centrifuges, N2 Evaporators, Plasma SPE extractors, Pl t t Milli Q-Water system. Team of 25 well qualified and f2 ll lifi d d experienced scientists. A list of 91+ validated methods which are rugged and reproducible.
V01/12/10
10
p y g Timelines considered after the receipt of study drugs All study reports are as per ICH E3 guidelines
V01/12/10
11
Audited & approved by WHO Geneva A Approved BA/BE facility by M H T k d f ili b MoH, Turkey. MCC South Africa - Certification for the Dossier submitted.. accepted MHRA - Dossier submitted & accepted. TGA Australia Dossier submitted & accepted. ANVISA, Brazil.
V01/12/10
12
V01/12/10
13
V01/12/10
14
Therapeutic Expertise
Oncology Endocrinology Anti-infective Urology U l CVS (Phase 2 & 3) (Phase 3 Anti diabetic) (Phase 3) (Phase 1 & 2) (Ph (Phase 1, 2 & 3)
The Team also has experience in working in the following Therapeutic areas: GI Rheumatology Rhe matolog Immunology Neurology Dermatology Womens Healthcare (Phase 3) (Phase 3) (Phase 1, 2 & 3) (Phase 2 & 3) (Phase 3) (Phase 3)
V01/12/10
15
V01/12/10
16
Apr 09 17 136
May 09 17 162
Jun 09 17 220
Jul 09 17
Aug 09 17
Sep 09 17
Oct 09 17
Nov 09 17
47 59
V01/12/10
17
V01/12/10
18
Your reliable l l partner f global Contract Research requirements. Y li bl local for l b l C R h i Dr. Sailendra Kumar Goswami (Vice P id t (Vi President CRO) Cadila Pharmaceuticals Ltd. - CRO s.goswami@cadilapharma.co.in
Jasmeet Bagga (Business eve op e ( us ess Development CRO) C O) Cadila Pharmaceuticals Ltd. - CRO bd.cro@cadilapharma.co.in
V01/12/10
20