Pharma Regulatory & licensing

Service
Business.
A.Vikram Sathish
Indian companies
have recently focused
a lot on R&D in the
pharmaceutical
sector.

•Many companies now spend

8% or more of revenues on
research.
•Many pharma companies are now
actively targeting international
companies for contract research
and manufacturing (CRAM) deals.

•Medicinal chemistry, custom

synthesis, and clinical studies are
some areas in which Indian firms
The global pharmaceutical
outsourcing market was worth
USD57.2 billion in 2007.
It is expected to grow at a CAGR of 10% to
reach USD76 billion by 2010.
Global market for Contract Research and
Manufacturing Services
(CRAMS) in 2007 is USD55.48
bn.
Out of the total global CRAMS market,
Contract research w a s
USD16.58 bn,
growing at a CAGR of 13.8% and
Contract manufacturing was
USD38.89 bn
accounting for the major share
 Indian pharma outsourcing market
USD1.27m in 2007 and is expected to
was valued at
reach USD3.33 bn by 2010, growing at a

CAGR of 37.6%.
The Indian CRAMS market stood atUSD1.21 bn in
2007, and is estimated to reach USD3.16 bn by
2010.
 SCOPE
• Pharmaceutical companies increasingly outsource to
third parties to save money, speed up processes and
get products into the market quicker.
• Outsourcing allows companies to focus on their core
competency areas and expedite the entire process.
• In Asia pacific, large biopharmaceutical companies
outsource to their local and regional partners.
• CRO's (Contract Research Organizations) move up the
value chain with the desire to serve only few global
customers rather than diversify in different areas.
• Additionally, they are slowly converting into SMO's
(Site Management Organizations), where protocol
development and monitoring takes place in addition to
R&D.
Outsourcing Business Space

Range of Services

From Clinical quantities to Commercial scale

Business Space
Discovery
Chemistry
Process R& D
Pipeline Intermediates
Matured Intermediates
BIG Pipeline API’s
PHARMA
Matured API’s
Dosage Development
Commercial Drug
Product
Discovery
Chemistry
Process R& D

Pipeline Intermediates
EMERGING
PHARMA Matured Intermediates
Pipeline API’s
Dosage Development
FINE
CHEMICAL Pipeline & Matured
COMPANIES Intermediates
Global Pharmaceutical Outsourcing

Estimated Potential Market:

Pharmaceutical Drug Formulated Drug

R&D Substance Supply
Supply
30-35 ~50 60-80
(in $ bn)

Current share of outsourcing in defined Contract

R&D/Manufacturing space is around ~$35 bn

Source: Dow Report, AD Little, Cardinal Health

Changing Face of Industry

Declining R&D output & high costs 
continue to pose challenges to 
profitability
Blockbuster drug launches expected 
to drop from 14 in ’03 to 4 in ’08
Drug Product Withdrawls (Vioxx) 
and safety concerns (Crestor)
By ’08 patent expirations will 
account for $ 72 bn in current sales
Leading
to

Global Outsourcing

DRIVERS
B. Cost
C. Increase Productivity
D. Speed up New product
Development
D. Expand skills &
Source: AT Kearney Report
Changing Face of Industry

Declining R&D output & high costs 
continue to pose challenges to 
profitability
Blockbuster drug launches expected 
to drop from 14 in ’03 to 4 in ’08
Drug Product Withdrawls (Vioxx) 
and safety concerns (Crestor)
By ’08 patent expirations will 
account for $ 72 bn in current sales
Leading
to

Global Outsourcing

DRIVERS
B. Cost
C. Increase Productivity
D. Speed up New product
Development
D. Expand skills &
Source: AT Kearney Report
 Facts & Figures - INDIA
• Highest number of FDA approved plants outside USA
• Largely English speaking workforce
• IT capital of the world
• Democracy of 1 billion
• TRIP compliant
• UK based legal system
• Structured and reasonably transparent financial markets &
banking system
• Dependent on oil for energy
• Well entrenched entrepreneurial culture & developed private
sector
• Superior education level
• Infra-structure in need of development
• Largest market-share in generic API production
• Export & Western oriented
 Changed IP Scenario in India
Global standards followed on IPM
CDAs, MoUs, Non-Use Agreements, etc – routinely
implemented
Work ethics & “Need-to-know” work practices
Employee Contracts & Employee retention
mechanisms
Legal provisions & remedies available
Qualified API source
Cheap Source of And
intermediates Efficient Process
R&D Resource

India is now being looked at as a

reliable source
across the value chain in
India Advantage / Disadvantage
Advantag
es
Cost Flexibility Speed

Ø Language

Ø Chemistry, Engineering, Regulatory & QA experience, Dosage

expertise

Ø Manufacturing Infrastructure
Disadvantag
es
ØCapability in Niche Segments (Ex. Controlled
Substances)

ØCommunication

ØEmotional blocks (Ex. Compliance, Generic

Challenges etc)
 Operational Issues & Focus

Medicinal CMC Formulation &

Chemistry Development Development

Track record
Expertise
QESH
Scope for Compliance
scale-up Capacity
Analytical Commercial
Sourcing
IP Security
Lead times
Skill
Stick to timing
Technologies
cGMP
Communicatio
n
 Causes for negative experiences

Provider specific issues:

Environmental issues; license to operate

Asset reliability
Quality issues

“Yes” means, I will do whatever I can, “No” is

culturally impolite
Communication Issues
Key Elements for Pharma Business

PRODUCT INDUSTRY SERVICE INDUSTRY

DIFFERENTIATORS
DIFFERENTIATORS
ØInnovation First to
Speed
Market
ØDelivery Quality
ØCost Cost
Frequency
ØCommunication
ØQuality
Transparency
ØGeographical Reach Quality
ØTrustworthiness
ØFlexibility
ØCustomer Delight

.. Favor India as
destination
Choosing the Right Partner in India;
a Selection Model

QUALIFIERS DIFFERENTIATORS
Global Interests
Speed
Ownership pattern
Costs

Final Partner
Regulatory
Communication
Compliance
Project
Financial Stability
Management
Understanding IP
Track Record
Reporting
Understanding
compliant
the
Capability &
West
Infrastructure
Changing Paradigm

Range of Services

From Clinical quantities to Commercial scale

Outsourcing services +
In License the product for
Indian & Asian Markets
India’s Conclusion of Strengths…

Speed

Competitiv
e Pricing

Full cGMP

…combining the best of both

worlds
Chan Advt’s
nel
Partn
Consulti
ng
Partner’
Growth = More
Business
Development
Consulting
Our consulting activities consist
of:
- Support in business
development
- Organizing meetings
- Developing the commercial
approach for a new product or
company
- Co-founding new business based
on promising new technology
Regulatory
Services
consulting
•Complete database for dossier
requirements
•Quick dossier compilation
•Draft pre-formulation, BMR, MFR, process
validation, method validation, dissolution
and stability studies documents
•Clinical and non-clinical overviews
•Justification for fixed dose combination
•Prepare Summary of product (SmPC) and
Pack Information Leaflet (PIL)
•Prepare label and carton contents 
•Reply to MOH queries
•Product registration assistance
•Product development assistance
•Global Patent Information
•Literature for patented product
•Non-infringing process
Regulatory
Complaiance
services
•CGMP / Quality System Auditing
•Internal GMP Audit
•Analytical Laboratory Audit
•Quality System Design &
Management
•Stability Program Design /
Implementation
•Regulatory Submission Preparation for
Drug Master File (DMF) in CTD
Certificate of Suitability (COS)
Dossiers in CTD
•Standard Operating Procedure (SOP)
Development
•Revised Schedule 'M' , WHO - GMP, US-
FDA,UK-MHRA , Australia - TGA , PIC/s
etc. implementation
Regulatory
Affairs services
we offer the following services:
•Technical Data Package for APIs and
Intermediates
•Drug Master Files for APIs and
Intermediates in CTD format or Country
specific Requirements
•COS/CEP Filing
•Drug Product Dossiers
•Site Accreditation
•Site Registration
•Product Registration
•Check List for Regulatory Audits
Product Registration &
Audit
•CGMP / Quality System Auditing
•Internal GMP Audit
•Analytical Laboratory Audit
•Quality System Design & Management
•Stability Program Design / Implementation

•Regulatory Submission Preparation (Product

Dossier) for the following :
•European Union (EU) - EMEA Guidelines
•Ministry of Health - Cambodia
•Ministry of Health - Ghana
•Ministry of Health - Myanmar
•Ministry of Health - Nigeria
•Ministry of Health - Slovakia
•Ministry of Health - Sudan
•Ministry of Health - Ukraine
•Ministry of Health - Vietnam       and many
more........

•Standard Operating Procedure (SOP)

Development Revised Schedule 'M' , WHO - GMP
, PIC/s , TGA etc. Implementation .
Product & Process
Development
•Formulation Development
•Excipient / Ingredient Selection
•Analytical Methods Development
•Product Development Report Writing
•Manufacturing Process Development
& Assessment
•Process Optimization and Validation
•Manufacturing Scale - Up
•SOP Development
•Technical Report Writing
•All work is done at reasonable cost
Technical dossier
Prepartaion
our own databank & sources to compile
,edit and create technical dossier on
various new and old Bulk drugs & Drug
intermediates.
Each technical dossier consists of the
following details :
•Drug details : CAS No., ATC Code,
Chemical name, Molecular formula,
Chemical structure, Nomenclature(s),
Licensor, Indication(s), Action ,
Therapeutic class.
•Synthesis scheme.
•Drug characterisation (by UV,FTIR,NMR,
DSC etc.)
•Physico-chemical properties.
•Analytical methodology.
•Impurity Profile.
•Patent abstract details.
Quality Assurance
services
•WSite Master File Preparation
•Validation e offer the following services:
•Master Plan Preparation
•Quality Manual Preparation
•Facility Validation
•Process Equipment Qualification
•HVAC/AHU System Validation
•Water System Validation
•Blending Validation
•Micronisation Validation
•Process Validation
•Cleaning Validation
•Standard Operating Procedures
•Documentation as per GMP regulations
•GMP Audits
•Check lists for Regulatory Audits
•Annual Product Review
•GMP Training Programmes
•Preparation of Product Manuals
Quality Control services
We offer following services:
•Quality Control Department
Establishment as per GMP
requirement
•Specification and Analytical
Procedure Development
•Standard Operating Procedures
•Instrument Logbook as per GMP
requirements
•Instrument Qualification
•Stability Study Protocols
•Preparation of Calibration Planner
•Preparation Stability Study Schedule
•Documentation as per GMP
regulations
•Test Protocols as per GMP
requirements
Partnering
Search
Our Partnering Search offers
advanced and enhanced partnering
support.
Actively working for you, our service
enables you to utilize our knowledge
and expertise.
A fully comprehensive solution
designed to complement your
existing business developement
activities.
As part of the service:
Based on your brief, our partnering
experts will search for partners on
your behalf and provide a fully
qualified list of target companies
(Prospect List)
On your instruction they will contact
Company
profiles
Our profiling service maximizes your
potential of finding the most suitable
partner for your opportunities by
targeting our focused global business
development and licensing audience.
Pharma licensing Service provides
potential partners from all around the
world. Whether you are looking to in-
or out-license, your profile allows
interested parties to contact you
directly with solutions that match
your needs.
post detailed information about
company and its business
development strategy,In- or out-
licensing opportunities, or services,
Fully categorised listings by sector,
Partner Identification
comprehensive consultancy services to support your partnering
activities.
Our unique service provides you with all of the elements of the
licensing process whilst also enabling you to minimize the time and
costs associated with it.
Fitting around your timescale and needs, we work with you as you
move through the individual elements of licensing at your own
pace.This flexible approach ensures you remain in control as you
progress from initial groundwork, through partner identification, to
negotiating and closing the deal.
Partner Introduction
Our partner introduction service helps you to progress from a
list of companies into active discussions. Following initial
review we will, where necessary, work with you to write or
improve your non-confidential dossier. This then forms the
basis of our initial approach and presentation to potential
partners. Building on these initial approaches we arrange
meetings for you to take negotiations further.
We work predominantly on a success fee basis; however the
initial upfront fee will vary depending on the status of your
non-confidential dossier at initial approach. It is vital that we
represent you with the best possible offering to potential
partners and will work closely with you to ensure this.
Partnership for
Due Diligence
Execution
with Panel team partnership We are proud
to offer comprehensive Service for Due
Diligence Execution.
For the first online research company and
has access to a global network of
professionals experienced in assessing
Intellectual Property ,product, Process &
Facility acquisition for clients including top
tier pharmaceutical and biotechnology
companies.
.
Representation & Deal
Closure
We provide you with a named industry expert who is on
hand to support and guide you at any time as you move
forward with your deal negotiations. Offering you as much
or as little assistance as you require, we bring experience
of many successful deals to the table to guide your
negotiations as they move through to closure.
All work is to pre-agreed contractual terms, which are
heavily biased towards success payments.
Thank You
Vikram
Sathish.A
Director -Marketing &