Aizant® Drug Research Solutions

Integrated Drug Development Solutions

Innovation|management|process |clinical www.aizant.com

We know the right balance of

cost, quality and expediency

Milestones

Aizant Incorporated

Beginning of Formulation Operation

Commissioning of cGMP facility

US FDA approval with no 483s

Recognition of R&D Center by DSI

Beginning Of Clinical operation

2005 2008 2009 2010 2011

ANVISA approval

NABL accreditation of Diagnostic Lab

WHO approval

MoH Turkey approval

TECHNOLOGYR&D

FORMULATON

COLLABORATE

COMMERCIAL ACCESS

INNO

VATI

ON

•Product Enhancement•505 b (2)•P - IV

•Pre Formulation•Salt Screening•Analytical Method Development

Identify

Develop

Partner

Implement

•Process Evaluation•Process Enhancement•Optimization

Strategy

Co-DevelopmentLicensing

Shared Services

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

SEZ Advantage

Jump start your project 4 weeks in advance to your competitor&

Give that extra mileage in your Drug R&D effort

Aizant

Other CROs

0

10

20

30

40

50

60

No.

of D

ays

API

RLD

RLD

API

Aizant can import API & RLD without waiting for import licenses due to it’s unique VSEZ advantage.

Quality

SOPGuideli

ne

TrainingDocumentation

Statistical methodolo

gies

Total quality managemen

tAizant’s Quality System

Serviceability

Conformance

Durability

Reliability

Performance

CDO: Services

Preformulation

• Reverse engineering

• Thermal analysis• Dynamic vapor

sorption• Particle size

analyser• Viscosity

measurements• Solubility studies• Dissolution

studies• XRPD, SEM, Hot

stage microscopy*

Formulation Development

• Dry blending• High shear

granulation• Fluid bed

granulation• Roller compaction• Extrusion

spheronisation• Wurster coating• Spray drying• Micronization• Pan Coating• Encapsulation

Analytical Development

• Method development

• Method validation

• Method qualification

• Method transfers• Stability studies• Chiral analysis• Microscopy

Other Services

• Scale-up and technology transfer

• Stand alone stability studies

• Product registration and regulatory support

• Clinical support• Upcoming facility

for potent substances

CDO:Infrastructure

-

About 40,000 SFT of F&D area scalable to 80,000 SFT at short notice

NDDSER,CR, MR ,SR dosage forms, Microencapsulation, MUPS,

Gastro retentive system

Topical Dosage Form & Parenteral dosage forms

Conventional dosage form:Tablet, Capsule, Liquids & Powders

Nano enabled formulation, Liposomes & Microsphere

Formulation : Accomplishments

Legend SIR Simple immediate release CIR Complex Immediate release SMR Simple modified release CMR Complex modified release Suspension Suspensions Combi Product Combination products Inj. InjectablesCT Chewable tablets ER Extended release

NCE New chemical entity

Legend LCM Life Cycle Management

IND Investigational New Drug

ANDA Abbreviated New Drug Application NDA New Drug Application

CIR13%

CMR16%C

ombi Product17%

CT2%

ER3%

NCE10%

SIR23%

SMR7%

Sus5%

Inj3%

ANDA94

IND10

LCM56

NDA6

cGMP: Services

Scale up

• Scale up of formulation development products

• Manufacturing batches for regulatory submissions

• Commercial manufacture of low volume products

• All kinds of packaging

Clinical trial material

• Investigational drug product

• Placebo • Encapsulation of

tablets, multiparticulate, capsules and other solid dosage forms

• Comparator manufacturing

• Clinical packaging, blinding, randomization

Analytics

• Testing and release of finished goods

• Cleaning validation/ process validation

• Microbiology• Stand alone

stability testing

Other Services

• Regulatory support

cGMP – Infrastructure

Process trains of Solid Orals- Upt Upto 15 kg - Upto 100 kg

About 10,000 SFT of cGMP area designed to meet FDA/MHRA standard

Flexibility of manufacturing batches from 0.05 Kg to 80kgs

OSHA compliance and other industry legislations

Temp : NMT 25±2°C; RH ≤ 55%Class

100,000Controlled environment

Clinical - Services

Clinical Pharmacology

• Clinical studies for males, females and special population

• BA/BE studies for global submissions

• Proof of concept studies

Bioanalytics

• Method development and validation

• Method transfer of drugs in biological matrix

• LCMS-MS and HPLC analysis of drugs and metabolites in biological matrix from clinical trial

PK&Biostatistics

• Study design• CRF review• Randomization

schedule• Statistical analysis

& reporting (SAS 9.2 and WinNonlin 5.2 software)

• Well trained staff

Diagnostics

•Hematology•Biochemistry•Immunology•Urine analysis• X-ray

CRO – Infrastructure

Volunteer database

Volunteer databaseMale: 2000+Female: 600+

Access to post menopausal women database

80 bed (2 clinics) facility spread over 28,000 sq feet

Bioanalytical laboratories equipped with 7 LCMS/MS including API 5500

In-house NABL accredited clinical diagnostics laboratory

Offsite storage of data for disaster recovery and business continuity

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

Clinical Study: Accomplishment

US66%

EU7%

Australia2%

WHO2%

Canada7%

Brazil16%

Turkey2%

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

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

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