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. The portfolio of the services include comprehensive Phase II-III clinical trials, regulatory submissions, phase IV post approval programs & commercialization services.

1. Regulatory
Exper/se
Manish
Kumar
Agarwal
Deputy
Manager,
Regulatory
Affairs

2. 2
Manish Kumar Agarwal
Deputy Manager, Regulatory Affairs
Experience
Manish Agrawal’s experience spans more than 4 years in Regulatory Affairs and includes 50+
submissions and 40+ regulatory approvals working with governing bodies like Central Drugs
Standard Control Organization (CDSCO), Directorate General of Foreign Trade (DGFT) and Port
Authority of India, Central Bureau of Narcotics (CBN) for various submissions and follow ups till
approval. In addition to working experience of the Central Drug Laboratory (CDL), Indian
Pharmacopoeia Commission (IPC), National Institute of Biologicals for various submission of
testing applications. In his current role as Deputy Manager, Regulatory Affairs he leads a team of
experienced Regulatory Affairs professionals.
Manish has attended more than 30 Subject Expert Committees/Medical Device Advisory
Committees at DCGI as well as Cellular Biology Based Therapeutics Dugs Evaluation Committee
(CBBTDEC) for different therapeutics indication studies.
Role
Key responsibilities include crafting client and study specific strategy for regulatory dossier
preparation, timely submission and approvals within the committed timeline.
Connected
Manish keeps in close contact with Technical Officers (TOs), Assistant Drugs Controller (ADCs)
and other relevant regulatory officers at Central Drugs Standard Control Organization (CDSCO)
for movement and timely clearance of dossiers which may include early query resolution.
Client’s Trust
With a passion for exceeding client expectations, Manish is trusted within the industry for his
expertise and ability to solve complex clinical trial issues. Clients regard him as an invaluable
component for the success of their trials.

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Asia-Pacific Regulatory Environment
Globally Accepted Data
The Asia-Pacific Region provides a progressive regulatory
environment focused on quality, transparency and protection
in research activities. Max Neeman consults with clients on best
locations for their particular clinical trial and market
commercialization needs.
Countries such as India, Bangladesh and Sri Lanka have
regulatory bodies that cooperate fully with international
regulatory agencies to ensure U.S. FDA, EMEA and ICH GCP
standards are met. As a result, Asia-Pacific is now central to a
majority of multi-national drug and device development
programs.
Similar to the United States and Europe, Asia-Pac’s diligent
approval processes ensure studies are conducted in an ethical
and transparent manner for globally accepted data.

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Asia-Pacific Regulatory Environment (continued)
Timelines And The Opportunity
Timelines to approval are driven by numerous factors such as
the protocol and quality of the Regulatory Dossier submitted,
experience and knowledge of necessary regulatory processes.
Max Neeman excels in this area because:
• Client and study specific strategy is crafted for regulatory dossier
preparation, timely submission for approvals within the committed
timeline
• Pre-submission examination and confidential regulatory meetings occur,
to ensure the dossier is complete and correct the first time it is submitted
• Quick query resolution by experienced regulatory team, for forward
movement and timely clearance of dossiers [if a query is raised]
• Critical awareness of Regulatory meeting schedules [ie: Ethics
Committees] to meet deadlines for timely submissions.
Once approved for clinical research, a population of over 1.5B
allows for rapid recruitment and study completion on-time.

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2014 Regulatory Process Improvements
Increased Approvals From India
The number of clinical trials approved in 2014 increased to
150, compared to 107 received in 2013 from DCGI – an
increase of ~40%.
This increase is due in large part, to the following regulatory
process improvements:
• Time-bound Clinical Trial Approval Process was initiated
[set scheduling, and more frequent committee meetings]
• Three tier review process established [SEC-Technical-Apex],
with the Apex meeting directly following Technical
• Registration of Ethics Committees with the Drug Regulatory
Authority
• Constitution of Independent Expert Committee for
recommendation on cause of SAE and quantum of financial
compensation
• Proper mechanism/formula established to calculate the
quantum of compensation

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Max Neeman’s Expertise
Hands-On Experience
Max Neeman’s regulatory team has thorough industry
knowledge and hands-on experience in working with different
regulatory agencies and is completely equipped to handle
Investigational New Drug (INDs), Ethics Committees and New
Drug Applications (NDAs).
Regulatory Services
• IND/Phase I Clinical Trials
• Phase II, III and IV clinical trials approvals for drugs
• Pilot and pivotal studies for devices
• Import licenses for investigational products, ancillary supplies and
equipment
• Export licenses for biologics
• Marketing authorizations for drugs
• Site and product registrations for drugs and devices
• Prepare and coordinate for Subject Expert Committee (SEC) and Medical
Device Advisory Committee (MDAC) at Drugs Controller General India
(DCGI) Office

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Max Neeman’s Expertise (continued)
Customized Regulatory Strategies
Max Neeman provides expert regulatory services to all
clients, working in consultation with them to develop
customized regulatory strategies. This process helps to
expedite the regulatory review and approval process.
Over a Decade of Experience
Max Neeman’s team has the following advantages:
• Regulatory knowledge in all phases of clinical trials to help navigate the
dynamic regulatory landscape across India and surrounding countries
• In house expertise to support clinical trial and marketing authorization
submission and post licensing support
• Service portfolio ranging from new chemical entities to biologics,
biosimilars, generic drugs and devices
• Knowledge of appropriate submission formats across Southeast Asia
• Strong relationships with national and regional regulatory agencies

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Max Neeman’s Expertise (continued)
Pre-Submission Meetings
Max Neeman corporate is in New Delhi, conveniently located
just down the road from India’s main regulatory bodies of
CDSCO & DCGI.
We have walked the halls and met with regulatory officials on a
regular basis since 2001 having pre-submission meetings to
discuss the best regulatory pathway for approval of clinical
trials. We have always done this to ensure our client’s dossier
submission has the best chance of receiving approval from the
start.
We offer ‘Regulatory Highlights in India’ on a regular basis
to all those interested. The email dated February 3rd states
CDSCO introduces official ‘Pre-submission meeting’ system. The
system will facilitate to understand the regulatory pathways
required to be followed by the applicants for approvals resulting
in bringing transparency, accountability, predictability and
speedy disposal of cases.

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Regulatory Timeline Case Study
Congenital Fibrinogen Deficiency Study
A case study on Congenital Fibrinogen Deficiency Study
demonstrates process to approval in five (5) months. Timelines
to approval are driven by numerous factors contingent upon the
protocol and quality of the Regulatory Dossier submitted.
Results
Max Neeman delivered results to include:
1. Application submitted to DCGI - April 7, 2014
2. Subject Expert Committee Meeting - July 4, 2014
3. Technical Committee Meeting - August 4, 2014
4. Apex Committee Meeting - August 4, 2014
5. DCGI Approval Received - September 12, 2014

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To Learn More
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