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Agenda

Overview of Max Neeman International

MNI Global Foot Prints

Therapeutic Expertise

Services

Regulatory Approval Process

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Max Neeman International

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It is our endeavor to become number 1 service provider

globally for small and medium size pharmaceutical and

biotech companies for monitoring and data management

services. We continue to be the number 1 service provider

for site management service to large pharmaceutical

companies.

We strive to deliver service excellence with the highest

ethical standards to our customers in developing drugs and

devices that have the potential to restore health and save

lives.

Vision & Mission Statements

Vision

Mission

Ethics & Core Values

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We commit to provide verifiable data to sponsors, regulators

and society with a focus on subject safety

Honesty and integrity

Highly quality driven

Subject safety first

Customer focus

Team work

Continuous learning and improvement

Dependable and sustainable

Core Values

Ethics Statement

Quality & Security Policies

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Max Neeman International is committed to provide quality

delivery of services to both external and internal customers.

We ensure this by using robust quality matrices. We will

continuously strive to achieve it by benchmarking all our

processes against global quality standards.

Confidentiality, Integrity and Availability of Max Neeman

Medical International Limited’s Critical and Sensitive

information assets shall be maintained through controls

commensurate with the value of the asset.

Security Policy

Quality Policy

Parent Company: Max India Limited

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Max India has been in operation since 1985 and is a multi-business

corporation, driven by the spirit of enterprise and focused on people

and service. The vision is to be one of India’s most admired

corporates for Service Excellence.

Consolidated turnover for FY14 was US $ 1936 million

and consolidated operating revenue was US$ 1514 million, a growth

of 12% above the same period last year

High growth path - with a customer base of 7 million, over 310 offices

across 216 locations in the country and people strength of 70,000

persons as on March 31, 2014.

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Operational since 2001

Full service CRO with focus on Phase II, III & IV trials for drugs; pilot and

pivotal studies for devices

325 awarded trials and number of patients enrolled for:

Phase I & II: 4715

Phase III: 14928

Phase IV: 169111

Device Studies: 7653

CRF entered for 130000+ patients

201 active sites in 43 cities with access to 900+ ICH-GCP trained

Investigators and a patient pool of 8 -10 million patients

1844 active sites in 57 cities for Phase IV studies

Total 250+ employees. 90% of team in clinical operations are Physicians

(MDs) and ICH GCP trained

Max Neeman International-Overview (1/2)

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Successfully completed 7 USFDA GCP Audits for Highest Enrollment

Globally. 2 US FDA audits completed in Sep 2012

ISO 9001:2008 certified organization for Site Management, Monitoring &

Clinical Data Management

ISO 27001 Certification received for ISMS (Information Security

Management System)

ISO 14155 Certification received for clinical investigation for Medical

Devices

Assessed for Malcolm Baldrige Performance Excellence Program

Operational presence initiated in Sri Lanka, Malaysia & Bangladesh

Total client base of 128 pharmaceuticals, biotech and medical device

companies across globe

Max Neeman International-Overview (2/2)

International Quality Certifications

Quality Management System

ISO 9001: 2008

Information Security Management System

ISO 27001:2005

Management System for Clinical Investigational plan

relating to Medical Devices

ISO 14155: 2011

Assessed for Malcolm Baldrige Performance Excellence

Program

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MNI Global Footprint

USA & Europe via strategic partnerships India/Asia Pacific Expertise

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Delhi

Mumbai

Chennai Bangalore

Ahmedabad

Office Locations

Corporate in Delhi, India

USA head office in Cary, NC

Over >200 sites across 43 cities

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Therapeutic Experience

Oncology18%

Endocrinology11%

Cardiology10%

Ophthalomology8%Devices

8%

Psychiatry6%

Gastroenterology7%

Dermatology6%

Neurology4%

Respiratory4%

Infectious Disease5%

Hematology5%

Nephrology2%

Rheumatology2% Others

4%

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Regulatory Advisory & Consultancy

Clinical Site Monitoring

Medical & Safety Management

Clinical Data Management

Medical & Scientific Writing

Pharmacy Services

Laboratory Services

Project Management

What we Offer?

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Chief Executive

Officer

Dr. Renu Razdan

Chief Operating

Officer

Mr. Kishor Kumar

Finance Controller

Ann Vawter

Director,

Business Devp. USA

Dr. Nilu Bhatia

Quality Assurance

and Audit

Management Team

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Management Team

Chief Operating

Officer

Director

Operations &

Regulatory

Dy. GM

Data

Management

Dy. GM

B D

Head Medical

& Scientific

Division

Human

Resources

Asst. Manager

Regulatory

Affairs

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Thank You

Contact Information:

Ann Vawter

Director, Business & Marketing

Max Neeman International

117 Edinburgh South Dr., Ste 105

Cary, NC 27511 P: 919.424.3332 / F: 919.852.5574

E: ann.vawter@neeman-medical.com

www.neeman-medical.com