Pharma Regulatory & licensing Service

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 are pitching and winning new business.

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 wasUSD16.58 bn,
growing at a CAGR of 13.8% and
Contract manufacturing was USD38.89 bn
accounting for themajor share (approximately 68%) of the total global pharmaceutical outsourcing market.

Indian pharma outsourcing market
was valued at USD1.27m in 2007 and is expected to reach USD3.33 bn by 2010, growing at a CAGR of 37.6%.
The Indian CRAMS market stood at USD1.21 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.

APIs
Discovery
Chemistry
Formulations
Advanced
Intermediates
Process
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
PHARMA
Pipeline API’s
Matured API’s
Dosage Development
Commercial Drug Product
Discovery Chemistry
Process R& D
EMERGING
PHARMA
Pipeline Intermediates
Matured Intermediates
Pipeline API’s
Dosage Development
FINE
CHEMICAL
COMPANIES
Pipeline & Matured Intermediates

Global Pharmaceutical Outsourcing Opportunity
Estimated Potential Market:
Packaging/
Assembly
Dosage
Form
Produc-
tion
Dosage
Form
Develop-
ment
Drug
Substance
Produc-
tion
Process
Develop-
ment
Clinical
Develop-
ment
Pre-
clinical
Develop-
ment
Discovery
Research
Pharmaceutical
R&D
Drug Substance
Supply
Formulated Drug
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
Cost
Increase Productivity
Speed up New product
Development
D. Expand skills & capabilities
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
Cost
Increase Productivity
Speed up New product
Development
D. Expand skills & capabilities
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
Economic growth in terms of GDP just slightly behind China

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

Cheap Source of
intermediates
Qualified API source
And
Efficient Process
R&D Resource
India is now being looked at as a reliable source
across the value chain in pharmaceutical industry

India Advantage / Disadvantage
Advantages
Cost
Flexibility
Speed

Language
Chemistry, Engineering, Regulatory & QA experience, Dosage expertise
Manufacturing Infrastructure

Disadvantages

Capability in Niche Segments (Ex. Controlled Substances)
Communication
Emotional blocks (Ex. Compliance, Generic Challenges etc)

Medicinal Chemistry
CMC Development
Formulation & Development
Operational Issues & Focus

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

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

Innovation First to Market
Cost
Quality
Geographical Reach

DIFFERENTIATORS
Speed

Delivery Quality

Cost
Frequency

Communication Transparency

Quality

Trustworthiness
Flexibility
Customer Delight

.. Favor India as destination

Choosing the Right Partner in India;
a Selection Model
QUALIFIERS
DIFFERENTIATORS

Global Interests
Ownership pattern
Regulatory Compliance
Financial Stability
Understanding IP
Reporting compliant
Capability & Infrastructure
Speed
Costs
Communication
Project Management
Track Record
Understanding the

West

Staff Quality

Final Partner

Discovery
Chemistry
Formulations
Advanced
Intermediates
APIs
Process
R&D
Changing Paradigm
Range of Services
From Clinical quantities to Commercial scale
Outsourcing services +
In License the product for
Indian & Asian Markets
Indian Companies are
positioning
themselves as partners to
Innovator companies

India’s Conclusion of Strengths…
Speed
Competitive Pricing
Full cGMP
…combining the best of both worlds

Channel
Partner
Advt’s

Consulting
Partner’s

Growth = More

Business Development ConsultingOur 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 target companies on your behalf to make introduction and coordinate initial contact/conference call etc (Hot List)

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, therapeutic target and disease

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 &Sales
Tri Inpharmex Services Pvt.Ltd