Max Neeman International is India’s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies.

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2. 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

5. 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

6. 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

7. 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)

10. 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
ChennaiBangalore
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
Oncology
18%
Endocrinology
11%
Cardiology
10%
Ophthalomology
8%Devices
8%
Psychiatry
6%
Gastroenterology
7%
Dermatology
6%
Neurology
4%
Respiratory
4%
Infectious Disease
5%
Hematology
5%
Nephrology
2%
Rheumatology
2% 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