Aizant is a contract research organization that provides integrated drug development solutions including formulation development, analytical development, cGMP manufacturing, and clinical services. It has facilities and capabilities across India that are FDA inspected. Aizant aims to reduce drug development costs by 30-35% through its services while maintaining quality and expediting timelines. It utilizes a project management approach and information technology infrastructure to efficiently execute projects.

1. Aizant® Drug Research Solutions
Integrated Drug Development Solutions
We know the right balance
of cost, quality and Innovation|management|process |clinical
www.aizant.com expediency

2. Milestones
US FDA approval ANVISA MoH Turkey
with no 483s approval approval
Beginning of
Formulation
Operation
Aizant WHO
Incorporated Commissioning approval
of cGMP facility
2005 2008 2009 2010 2011
Beginning Of
Clinical operation Recognition of
NABL accreditation
R&D Center by
of Diagnostic Lab
DSI

3. Strategy
FORMULATON
•Product Enhancement
•505 b (2)
•P - IV
Licensing Co-Development
Identify
Develop
Partner
R&D TECHNOLOGY
•Pre Formulation •Process Evaluation
•Salt Screening •Process Enhancement
•Analytical Method Implement •Optimization
Development
Shared Services

4. Advantage Aizant
Reduce R&D costs by 30% to 35%.
Save up-to 35 to 37 FTEs annually
Jump start R&D project 4 weeks ahead of your competitor
Realize a team of amazing innovators at 1/4th of your local hourly rate, equivalent, &
extension to your core development team
40%-45% reduction in capital-intensive investment and utilize the saving for mission
critical R&D
We follow Quality by design concept the impact is successful R&D outcome with lesser
no. of experiments
Access smart labs with web-cam enabled facility for remote monitoring of your projects
saving 50% - 55% of travelling cost & time
Aizant operate as full service CRO enabling you save cost, time, and effort for multiple
vendor management
Improve ROI of your R&D budget @ 20-25% YoY utilizing extra 2 hrs of R&D effort due to
time zone difference and 6 day a week work culture

5. SEZ Advantage
Jump start your project 4 weeks in advance to your competitor
&
Give that extra mileage in your Drug R&D effort
60
50
No. of Days
40
30 A R
P L
A I D
20 R
P
I L
10 D
0
Aizant
Other CROs
Aizant can import API & RLD without waiting for import licenses due
to it’s unique VSEZ advantage.

6. Quality
Total quality
SOP
management
Serviceability
Performance Conformance
Statistical Aizant’s
Guideline
methodologies Quality
System
Reliability Durability
Documentation Training

7. CDO: Services
Formulation Analytical
Preformulation Other Services
Development Development
• Solid State • Dry blending • Method • Scale-up and
Characterization • High shear development technology
• Thermal analysis granulation • Method transfer
• Dynamic vapor • Fluid bed validation • Stand alone
sorption granulation • Method stability studies
• Particle size • Roller compaction qualification • Product
analyser • Extrusion • Method transfers registration and
• Viscosity spheronisation • Stability studies regulatory
measurements support
• Wurster coating • Chiral analysis
• Solubility studies • Clinical support
• Spray drying • Microscopy
• Dissolution • Upcoming facility
• Micronization
studies for potent
• Pan Coating substances
• XRPD, SEM, Hot • Encapsulation
stage
microscopy*

8. CDO:Infrastructure
About 40,000 SFT of F&D area scalable to
80,000 SFT at short notice
Conventional dosage form:
Tablet, Capsule, Liquids & Powders
NDDS
ER,CR, MR ,SR dosage
forms, Microencapsulation, MUPS, Gastro retentive system
Topical Dosage Form & Parenteral
dosage forms
-
Nano enabled formulation, Liposomes &
Microsphere

9. Formulation : Accomplishments
Sus Inj CIR
NDA
SMR 5% 3% 13% 6
7%
CMR LCM
16% 56
SIR
ANDA
23% 94
Combi
Product
NCE ER CT 17% IND
10% 3% 3% 10
Legend Legend
SIR Simple immediate release LCM Life Cycle Management
CIR Complex Immediate release IND Investigational New Drug
SMR Simple modified release ANDA Abbreviated New Drug Application
CMR Complex modified release NDA New Drug Application
Suspension Suspensions
Combi Product Combination products
Inj. Injectables
CT Chewable tablets
ER Extended release
NCE New chemical entity

10. cGMP: Services
Scale up Clinical trial material Analytics Other Services
• Scale up of • Investigational • Testing and • Regulatory
formulation drug product release of support
development • Placebo finished goods
products • Encapsulation of • Cleaning
• Manufacturing tablets, multipar validation/
batches for ticulate, capsule process
regulatory s and other solid validation
submissions dosage forms • Microbiology
• Commercial • Comparator • Stand alone
manufacture of manufacturing stability testing
low volume • Clinical
products packaging, blindi
• All kinds of ng, randomizatio
packaging n

11. cGMP – Infrastructure
About 10,000 SFT of cGMP area designed to
meet FDA/MHRA standard
OSHA compliance and other industry
legislations
Flexibility of manufacturing batches
from 0.05 Kg to 80kgs
Class Controlled environment
100,000 Temp : NMT 25±2°C; RH ≤ 55%
Process trains of Solid Orals
- Upt Upto 15 kg
- Upto 100 kg

12. Clinical - Services
Clinical PK
Bioanalytics Diagnostics
Pharmacology &Biostatistics
• Clinical studies for • Method • Study design •Hematology
males, females development and • CRF review •Biochemistry
and special validation • Randomization •Immunology
population • Method transfer schedule •Urine analysis
• BA/BE studies for of drugs in • Statistical analysis •X-ray
global submissions biological matrix & reporting (SAS
• Proof of concept • LCMS-MS and 9.2 and WinNonlin
studies HPLC analysis of 5.2 software)
drugs and • Well trained staff
metabolites in
biological matrix
from clinical trial

13. CRO – Infrastructure
80 bed (2 clinics) facility spread over 28,000
sq feet
In-house NABL accredited clinical
diagnostics laboratory
Bioanalytical laboratories equipped
with 7 LCMS/MS including API 5500
Offsite storage of data for disaster
recovery and business continuity
Volunteer database
Volunteer database
Male: 2000+
Female: 600+
Access to post menopausal women database

14. Clinical: Regulatory approvals
• US FDA audited facility with NO 483s
• ANVISA inspection successfully completed (No
major or critical observations)
• NABL accreditation for clinical diagnostics
• DCGI inspected and approved
• WHO approved
• Turkey MoH approved
• Working on EMEA inspection

15. Clinical Study: Accomplishment
US
66%
Turkey
2%
Brazil
16%
Canada EU
6% 6%
WHO Australia
2% 2%

16. Project management
• Cross functional project teams from
formulation, analytical, quality and regulatory
departments
• All projects teams are monitored on MS projects
by an experienced project manager
• Metrics based project planning and execution
• Well defined communication systems as decided
at beginning of project
• Good track record of completing projects on time

17. Information technology
• Data-centre with backup and recovery facility
• Offsite data storage for disaster recovery
• IP Cameras for remote virtual monitoring of
projects
• Biometrics for cross-check and validation
• Well defined IT policy for security and access
control
• Metrics based reporting

18. Contacts
Aizant Drug Research Solutions Pvt. Ltd.
Sy. No. 172 & 173, Apparel Park Road,
Dulapally, Hyderabad, India – 500014
Phone: +91 -9177172188
E-mail: info@aizant.com, Website: www.aizant.com