Bishwjit Ghoshal_Summer Internship Report 2015

A Summer Internship Project
Market Opportunity Assessment for
‘Alpha’ products of ‘AB Pharma’
June 4th- August 4th, 2015

Market Opportunity Assessment for Alpha products
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Preparedby,
Bishwjit Ghoshal
Summer Intern, PharmaAce Analytics
MBA (Pharm.)
DOPM, NIPER-Mohali
Guided by,
Ms. Onisha Dhar
Consultant, PharmaAce Analytics
Pune
Mr. Amit Pharande
Consultant, PharmaAce Analytics
Submitted to,
Dr. Anand Sharma, Ph.D.
Professor, In-charge,
Dept. of Pharmaceutical Management
NIPER-Mohali

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TABLE OF CONTENTS:
1. Acknowledgement………………………………………………………….4
2. Preface………………………………………………………………………5
3. Declaration………………………………………………………………….6
4. Executive Summary………………………………………………………..7
5. Company Profile……………………………………………………………9
6. ProjectWork……………………………………………………………...11
Therapy Analysis……………………………………………………..11
Pipeline Analysis………………………………………………….11
Cell Therapy Industry……………………………………………..16
GeographicalMarketAnalysis……………………………………...20
CustomerProfiling…………………………………………………...24
Competitors’Analysis………………………………………………..26
7. Learnings…………………………………………………………………..27

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Acknowledgement
An internship project is a golden opportunity for learning and self-development. I consider
myself very lucky and honored to have so many wonderful people lead me through in
completion of this project.
I take this opportunity to express my profound gratitude and deep regards to my guides Mr.
Amit Pharande and Ms. Onisha Dhar, consultants at PharmaAce analytics, Pune for their
exemplary guidance, monitoring and constant encouragement throughout the course of this
thesis.
I also take this opportunity to express a deep sense of gratitude to Mr. Anuj Kumar, Delivery
Head, PharmaAce analytics for his cordial support, valuable information and guidance, which
helped me in completing the task through various stages.
I am obliged to all team members of PharmaAce analytics, Pune for the valuable information
provided by them in their respective fields. I am grateful for their cooperation during the period
of my assignment.
A humble thanks to our beloved Professor Dr. Anand Sharma, Associate Professor, In-charge,
Dept. of Pharmaceutical Management, National Institute of Pharmaceutical Education and
Research- Mohali whose help, suggestions and encouragement gave the right direction toward
completion of project.
Lastly, I thank almighty, my parents and friends for their constant encouragement without which
this assignment would not be possible.

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Preface
It has been an immense pleasure for me to present research on “Market Opportunity
Assessment for ‘Alpha’ products of ‘AB Pharma’” as a part of curriculum of my
course MBA in Pharmaceutical Management.
It was a great learning during two months of my training period. This project gave me an
opportunity to have an understanding on Knowledge services value chain including Secondary
market research, Data analysis, Reporting and Business development. I would like to thank all
experts for giving their valuable time and data that helped me to complete my project.
I would like to thank PharmaAce analytics for giving me an opportunity to work on this
project. Once again my sincere thanks to Mr. Anuj Kumar, Delivery Head and my guides Ms.
Onisha Dhar and Mr. Amit Pharande, Consultants, PharmaAce analytics, Pune for guiding me
during this project. Without their guidance it wouldn’t have been possible for me to complete
this project.

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Declaration
I hereby declare that project titled “Market Opportunity Assessment for Alpha Products”
original piece of analytical work carried out by me under the guidance and supervision of Mr.
Anuj Kumar, Delivery Head; Ms. Onisha Dhar and Mr. Amit Pharande, consultants,
PharmaAce analytics. The information has been collected from genuine & authentic sources. The
work has been submitted in partial fulfilment of MBA (Pharm.) degree in Dept. of
Pharmaceutical Management, National Institute of Pharmaceutical Education and Research
(NIPER) - Mohali.
Name: Bishwjit Ghoshal
Signature:
Date: October 15, 2015

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Executive Summary
About the Project- Market OpportunityAssessment:
Our client AB pharma manufactures components and systems for injectable drug delivery and
plastic packaging, and delivery system components for the healthcare and consumer products.
The project was related to the market opportunity assessment for one of its breakthrough
products i.e. Alpha.
About the Product: ‘Alpha’
Alpha is the unique insert needle design that minimizes potential contamination and product
waste caused by manufacturing and performance issues associated with traditional glass and
staked-needle syringe systems.
The core competencies of the product can be divided into 3 sections:
 Minimize Risk
• Highly break resistant
• No silicone oil, tungsten and adhesive in the drug contact areas
• Very low visible and subvisible particles
• Maximizes stability, purity and efficacy of your drug product
• Manufactured to exacting standards in a clean room environment
• Assurance of an established material from the market leader in drug packaging
materials
• Established relationships with leading contract fillers
 Maximize Value
• 100% vision inspection to minimize defects
• Potential to reduce protein aggregation caused by loose particles, tungsten, and silicone
oil
• Excellent glass-like transparency
• Minimal investment in additional manufacturing technology
• Suitable for sensitive drugs and biologics
• Potential to reduce total cost of ownership

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 Enhance Delivery
• Superior functional performance without silicone oil
• Overcomes the limitations of glass
• Suitable for high-viscosity products
• Dimensional precision for optimal performance in delivery devices
• Predictable piston release and travel forces over time
• 100% X-ray inspection of the needle minimizes defects that may increase injection pain
• Suitable for drug products that require low-temperature storage
• Custom design and molding capabilities provide the flexibility to develop innovative
new systems
About Project Research:
The activities performed during the execution of project can be classified into four sections. The
sections have been formed based on the commonality in the activities performed.
SECTIONS ACTIVITIES
THERAPY ANALYSIS
 Analysis of 566 phase 1 oncology drugs
 Pipeline Assessment of 1120 all phase
oncology drugs
 Pipeline assessment of818 drugs- all phase-
various diseases
 Cell Therapy Industry Analysis
 Analysis of Phase 2 SC biologics
GEOGRAPHICAL MARKET ANALYSIS
 Assessment of Japan as a market for AB
Pharma
 IV Fluid Bag Market
CUSTOMER PROFILING
 Preparation of decks of potential customers of
our client:
(a) Alkermes; (b) Baxalta
COMPETITORS’ ANALYSIS
 Analysis of the potential competitors for the
client in the following fields:
(a) Devices,
(b) Contract Manufacturing,
(c) Patient Services,
(d) Labs & analytical services providers

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1. Company Profile
PharmaAce Analytics Private Ltd, Pune
A US-headquartered life sciences focused company that provides analytic solutions for efficient
commercialization of pharmaceutical products. Its services are designed to provide clients with
business critical research and insights enabling them to make informed decisions related to their
sales and marketing. It helps Life Sciences companies address challenges spanning across
commercial functions. It delivers custom made solutions addressing the critical business
question. Institutionalizing analytics driven decision making through value demonstration.
How does PharmaAce helps its clients globally?
• Identify activities/positions that are offshorable in ensuring cost containment
• Onshore/offshore support optimization
• Migrate processes for cost/quality benefits
• Process standardization and improvement
• Value driven delivery and engagement models
• Creating service level benchmarks

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Services Offered
The services offered by PharmaAce analytics can be divided into two sections.
MARKETING
ANALYTICS
• FORECASTING
• COMPETITIVE INTELLIGENCE
• MARKET ASSESSMENTS AND SIZING
SALES
ANALYTICS
• PERFORMANCE REPORTING
• SALES ANALYTICS AND DASHBOARD
• SEGMENTATION
ENGAGEMENT MODEL
Project Based Engagement
Flexibility while engaging without any
long term commitments
Cost containment in comparison to on
shore team
A reasonable “Proof of Concept” model
Flexible Services Model
Common resources and shared learning
over multiple projects
Real time analyst support
Alternative to internal expansions in
addition to bringing in cost efficiencies

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THERAPY ANALYSIS
Under therapy analysis, following activities were performed:
 Analysis of 566 phase 1 oncology drugs
 Pipeline Assessment of 1120 all phase oncology drugs
 Pipeline assessment of 818 drugs- all phase- various diseases
 Cell Therapy Industry Analysis
(A) PIPELINE ANALYSIS
Pipeline analysis involves the analysis of the products of different companies belonging
to different classes that are not yet in the market and are in developmental stage. This
involves the drugs that are in 1st
, 2nd
or 3rd
stage of clinical trials.
Under this, analysis of 566 phase 1 oncology drugs, 1120 drugs all phase oncology drugs
and 818 drugs, all phase, various diseases.
Oncology: Some facts and figures
 Global cancer incidence rates are expected to increase over the next 20 years by a
rate of 75% from 12.5 mn patients in 2008 to 22.5 mn patients in 2030.
 The market has increased from roughly USD 9 bn in 1998 to USD 70 bn in 2013.
It is estimated that by 2018 the oncology market will reach more than USD 110
bn with a CAGR of 9.0
 At present there are more than 500 oncology products are in pipeline which is
way more than any other therapeutics area.

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Why Oncology?
 High unmet needs:
Nearly all metastatic solid tumors are uniformly fatal and many opportunities to improve
outcomes in earlier stages
Significant unmet needs remain in many hematologic malignancies, despite progress
 Receptive innovation:
Key actors in market generally have been receptive to innovation (providers, patients,
payers, regulators)
 Favorable dynamics:
Limited & concentrated provider universe
Historically favorable pricing, reimbursement & access environment

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METHODOLOGY:
The methodology for carrying out pipeline analysis involves Top Down approach in which we
start from total oncology products, and subsequently screen based on various parameters to
eventually arrive at a list of potential products. These products are then scored and ranked.
1. Database of oncology products from PharmaCircle is looked into
PharmaCircle is a paid database having information from various sources like patents,
company websites, clinical trials records and daily news feed. The reason for its selection
is its extensive coverage that includes 10000+ companies, 26,000+ molecules, 37,000+
FDA products and many more.
2. Validation of details by performing Secondary Research
The data and information given by PharmaCircle was needed to be validated upon before
including that into the final output. The secondary search was done to ensure its
authenticity. The sites included in secondary search were clinicaltrials.gov, umin,
ascopubmed, ncbi, etc.
3. Removal of unwanted products from PharmaCircle list
Three different pipeline analyses were performed. In the first and the second project, only
phase 1 active trials were required. Thus, all the other products that were in other phases
and the ones in phase 1 which were inactive, suspended, terminated were eliminated from
the list.
Similarly, the third activity that included the products from all phases and all diseases, no
such filtering was done.

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4. Scaling of parameters
Not all the parameters assigned to the drugs hold equal weightage. Thus, in scaling the
parameters are assigned weightage in accordance with their importance. The scores are
provided on a scale of 1-3 and final scores are calculated by multiplying weightage and
scores.
A Snapshot of the rating mechanism
used

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5. Sorted List of Products
Finally, based upon the scores calculated for the products, ranking is given to them and
the top products and companies are found out.
Summaryof all oncologyPhase 1
opportunities for CZ
1
16.95
14.9
13.45
13.3
11.25
10.75
10.35
10
9.8
9.5
9.35
9.35
9.3
9.15
8.35
7.15
7.05
6.75
6.3
6
7
7
7
6
5
5
6
5
5
5
6
5
4
4
5
4
4
5
3
3
Bristol-Myers SquibbCo.
Pfizer Inc.
GlaxoSmithKlinePlc
AbbVieInc.
Roche
Amgen Inc.
Genentech,Inc.
Regeneron Pharmaceuticals Inc.
Immunogen Inc.
Medimmune,LLC
Inovio Pharmaceuticals, Inc.
Seattle Genetics Inc.
OncoMed Pharmaceuticals, Inc.
ImcloneSystems Inc.
Immunomedics Inc.
Agensys,Inc.
JunoTherapeutics, Inc.
OncoTherapy Science, Inc.
Daiichi Sankyo CoLtd.
MacroGenics, Inc.
Score No.of Molecules
Top 20 companies based on product scores
Remaining 285 institutes have an average score of <6
• Companies are ranked based on the
cumulative score of their potential products
• Major companies that have a lot of
potential molecules for CZ are BMS, Pfizer
GSK, Abbvie, Roche, Amgen etc.
64%
15%
12%
9%
IV NA
IMor SC Others*
48%
29%
22%
1%
Large Small
Cell Therapy NA
Most of the oncology products are Large molecules
and are administered intravenously
Route of Administration Molecule Type
Note: *Others comprise of intranodal, intradermal, intraperitoneal, intratumoral
and intrapleural; NA: Information Not avaiable

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(B) CELL THERAPY INDUSTRY
 Cell therapy is defined as the administration of live whole cells or maturation of a
specific cell population in a patient for the treatment of a disease
 Cell therapy treatment strategies include isolation and transfer of specific stem cell
populations, administration of effector cells, induction of mature cells to become
pluripotent cells, and reprogramming of mature cells
 Various disease in which cell therapy is being used nowadays include blood
disorders like anemia, leukemia, lymphomas and certain types of immunodeficiency
diseases
Cell Therapy
Mainstream Medicine Alternate medicine
Cells of a human donor are
injected into the recipient
Animal materials are injected in
order to cure diseases
Allogeneic Cell
Therapy
Human
embryonic stem
cell therapy
Neural Stem Cell
Therapy
Mesenchymal
Stem Cell
therapy
hematopoietic
stem cell
therapy
Stem Cells
Services
Cord Blood
Banking
Bone Marrow
Transplants
Stem Cell
Therapies

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Cell Therapy Projects by Therapy Area:
MajorPlayers in CellTherapy:
• BRITS team’s analysis of the 592 commercial cell therapy
projects that were identified highlights that the cell therapy sector
is a sector that spans all key therapeutic application areas
• Oncology constitutes the largest area in which new cell therapies
are being developed as 26.2% of cell therapy projects
• Followed by neurology (15.4%), alimentary/metabolic (13.4%),
cardiovascular (11.3%), and musculoskeletal as the largest
therapeutic markets cell therapy projects

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Current MarketedProducts
Product Company Description Route of Administration
Carticel Genzyme Autologous Cultured
Chondrocytes
Implantation of intraspinal
catheter
Epicel Genzyme Cultured Epidermal
Autograft
Topical Application
Cartistem Medipost Mesenchymal Stem
Cells derived from
umbilical cord blood
Surgical Administration
Apligraf Organogenesis Living Bi-layer skin
substitute
Topical Application
Grafix Osiris Therapeutics Cryopreserved
placental membrane
Topical Application
DeNovo Nt Zimmer and ISTO
Technology
Cartilaginous
Allograft tissue
Implantation
Trinity Evolution Orthofix Mesenchymal Stem
Cell
Implantation
Provenge Dendreon Autologous Cellular
Immunotherapy
Intravenous
BioDfence BioDlogics Allograft from Human
amniotic tissue
Implantation
ChondroCelect Tigenix Autologous Cartilage
Cells
Implantation
LaViv Fibrocell Autologous Cellular
Product
Intradermal
MACi Genzyme Autologous
Chondrocytes
Implantation

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Drivers and Barriers for Cell Therapy Market
DRIVERS BARRIERS
 Advances in Basic science
revealing the nature of cell growth,
differentiation and proliferation
 Advances by industry to
manipulate and determine cell
growth towards specific
therapeutic solutions
 Low barrier to entry for
competitors in the market
 Broad range of applications for
cell/tissue advances to many
different specialties with modest
adaptation needed
 Strong venture funding
• Regulatory pathways still
emerging and can be complex
• Investor avoidance of pre-clinical
phase programs
• Hard to manage demonstration of
clinical safety and efficacy
• Move from small scale GMP
process to large scale
manufacturing is difficult
• New model of delivery required

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GEOGRAPHICAL MARKET ANALYSIS
 JAPAN’S MARKET: A SOURCE OF IMMENSE OPPORTUNITIES
Japan as a market is a very attractive destination for our client. Its old age population,
favor to generic products, etc. prove to be favorable factors for a pharmaceutical
company.
AN OVERVIEW:
 Japan is the World’s second largest pharmaceutical market by country
contributing to ~9.7% of the total world pharmaceutical market
 Japan is the second largest medical device market in the world, behind USA and
is the World’s 3rd
largest device importer
 A relatively low barrier to reimbursement compared to many EU markets with a
streamlined reimbursement system compared to the complicated processes in
other countries and where Pharmacoeconomics analysis is rarely used to make
listing decisions
 Until recently the Japanese pharma market, has traditionally been thought of as
isolated with domestic players mainly focused on servicing the local markets.
Now, the Japan market is becoming more open, both to foreign companies
entering the Japanese market and to Japanese companies investing abroad
 Around $ 1.7 billion worth of biosimilars are going off patent in 2015 in Japan
making it lucrative for the companies and diagnosis procedure combination
(DPC) system hospitals. Anticipating the opportunity and favorable macro-
forces, a number of companies planning to enter the Japanese market
 With new policies that favor generic growth, generic players across the globe are
eyeing Japan’s markets

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Trends in the JapaneseMarket
 Establishing International Presence
 Finding domestic growth opportunities amidst Japan’s biennial drug price
reduction initiatives is very difficult
 In the last several years, a number of Japan's larger pharma companies have been
branching out by setting up R&D sites around the world
 Mergers and Acquisitions
 With very few blockbuster drugs in the market and scarce innovative treatments
in the pipeline, pharma companies around the world are refining their research
priorities and consolidating growth with a tendency for aggressive mergers and
acquisitions (M&A)
 Japanese pharmaceutical companies, who were relatively absent from M&A
activities as compared to global trends, are also eyeing M&A opportunities in new
markets
 Foreign Participation growing in Japanese pharmaceutical sector
 Traditionally international firms have struggled to adapt to Japan's regulatory
system and working culture, but today most major pharma companies maintain a
successful presence
 Government reforms like greater harmonization with EU and US regulatory
regimes and R&D tax credits have helped persuade companies to set up shop in
Japan
 Japan has gradually become a popular destination for multi-regional clinical trials
(MRCTs) since 2006, shortening the time and expense involved in getting new
drugs to Japanese patients safely

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 Favorable policies for Generic growth
 Japan is attempting to incentivize higher use of generic drugs as a means to
reduce healthcare spending
 Generic drugs have struggled to gain share in the Japan market until recently
 Unconfirmed reports suggest that Japan’s government wants generic penetration
of 60% in 2017, up from just 30% in 2014
 Thus generic manufacturers from around the world - especially generic specialists
like India - are looking to Japan as a source of future expansion
MedicalDevice RegulatoryPathway
1. Determine Regulatory Pathway
 Device classification according to the PMDL
(Class 1, 2, 3, 4; classes are rated as per increasing risk to patient or user) and
 Availability of a JMDN code
(Broadly based on Global Medical Device Nomenclature) Need fluency in
Japanese to make correct selection)
2. Appoint Market Authorization Holder
 Manufacturers with no local presence in Japan must appoint a Marketing
Authorization Holder (MAH) or Designated MAH* to
Manage their device registration process and
Liaise with the PMDA, Japan’s medical device market regulator
3. Submit Foreign Manufacturer Accreditation Application
 Submitted to the PMDA by your MAH/DMAH
 Application for medical device Foreign Manufacturer Accreditation (Form No.
18)
 Supporting documentation such as medical certificates, product lists and facilities
summaries
 Registration form to obtain a manufacturing code

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 Domestic manufacturers must register their manufacturing facilities with their
local prefectural authorities
4. Quality SystemCompliance
 For Class II, III and IV devices manufacturers
 Compliant with the PAL and MHLW Ordinance #169 (Japan QMS Regulation)
 Submit QMS Conformity Assessment Application
 Similar to ISO 13485 and US Quality System Regulation (21 CFR Part 820)
5. Submission to PMDA or RCB
 Based on class
 Class 1: Submit pre-market submission to PMDA
 Class 2(Specified Controlled ): Submit pre-market Certification Application to
Registered Certification Body
 Class 2, 3, 4: Prepare Pre-market Approval Application and Supporting
documents as attachment with documents in Summary Technical Document
Format and Submit to PMDA
 The PMDL will allow more Class II as well as some Class III devices to qualify
for third-party certification
6. Quality SystemAuditing
 Based on class
 Class 2(Specified Controlled ): QMS Audit by RCB
 Class 2, 3, 4: QMS Audit by the PMDA for foreign manufacturers or by the
Prefectural Regulatory Authority for domestic manufacturers
 The PMDA conducts on-site audits for new medical devices, Class IV devices
and devices requiring clinical investigations
7. Final PMDA or RCB certification
 Class 1: Self-declaration; No Certification from PMDA (0mths)
 Class 2(Specified Controlled ): Pre-market Certification issued by RCB (3-6
mths)
 Class 2, 3, 4: Pre-market Approval Certificate Issued by MHLW; Certificate does
not expire (8-16mths)
 Approvals do not expire but are subject to ongoing QMS requirements.

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CUSTOMER PROFILING
Our client being a producer of drug delivery devices is constantly in search of the customers that
can use its devices to dispense their medications.
During the search for ideal customers, two companies i.e. Alkermes and Baxalta were analyzed
upon and decks were prepared.
Reasons for the selectionof Alkermes and Baxalta
 Both Baxalta and Alkermes are emerging companies. It is easier for our client to tap the
emerging companies than the more established ones.
 There has been a steady increase in the revenue of both these companies. This implies the
higher sale of products of these companies making them a perfect partner to work with.
 Alkermes and Baxalta have collaborations with big companies regarding one or more
products. This provides our client an indirect access to these big companies via them.
 Majority of the inline as well as pipeline products of Baxalta and Alkermes are
injectables. Since, the core competency of our client is in injectables section, this makes
them a perfect match.
 Both the companies are involved with the manufacture of biologics. Since, the most
preferred route for biologics is through injections, thus, the companies are good options
for our client..

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Attributes
Location
Wilmington, US; Dublin,
Ireland; Athlone, Ireland;
Gainesville, US; Waltham,
Massachussetts
Cambridge, Massachussetts;
Northern Illinois, US
Revenue $618.78 mn (2014) $6 bn (2014)
Business Partners Johnson & Johnson; Lily; Elan
technologies; Acceleron; Astra
Zeneca; Acorda; Civitas
Nektar; Kaketsuken;
Halozyme; Kamada;
Momenta; Onconova;
Coherus; Cti; Merrimack
Inline Products Risperdal Consta; Vivitrol;
Bydureon; Ampyra; Xeplion;
Invega Sustenna
Advate; Rixubis;
Recombinate; Bebulin; Feiba;
Obizur; Hyqvia; Aralast;
Glassia
Pipeline Products ALKS 5461; ALKS 3831;
ALKS 8700; RDB 1450;
ALKS 7119
BAX 817; BAX 111; BAX
855; BAX 335; BAX 930;
BAX 2200; SM 101; BA 923;
Gammagard Liquid; etc

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COMPETITORS’ ANALYSIS
• With the passage of time, AB is planning to explore new geographies and along with that
new dimensions what it has not touched yet
• AB, being a leader in packaging devices, now plans to move into other areas like contract
manufacturing, Patient consultancy services and analytical services sector
• The competitors’ analysis section gave an overview of the potential competitors that AB
needs to face in its area of expertise i.e. Medical Devices and the areas that it is yet to
explore
Process:
• The competitors’ analysis process consisted of first identifying the competitors that AB
has in various fields
• After the identification, information was gathered with regard to their location, their
revenue, history, core competencies and most important, the services each of them
provide
• The companies analyzed belonged to 4 sectors:
 Medical Devices
 Contract Manufacturing
 Patient Consultancy Services
 Labs and Analytical Services Providers

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Competitors of AB Pharma (Devices, Contract Manufacturing & Patient Services)
Competitors of AB Pharma (Labs and Analytical Service Providers)
LEARNINGS:
1. ART OF PRESENTATION
 Present information in a compact manner
 To say a lot in few words
2. INTRODUCTIONTO CONSULTING
Got introduced with various aspects of consulting:
 Market analysis
 Competitive intelligence
 Pipeline assessment

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3. CLINICAL TRIALS SEARCH
 Search of around 2000 drugs
 Good practice of clinical trials search
 Awareness of the sources of clinical trials, eg clinicaltrials.gov; ASCO pubmed;
UMIN.ac.jp; etc.
4. DATA ENTRYAND ANALYSIS
 Good practice of excel
 Got introduced with new features of excel and their usage
5. DATA VALIDATION
 Got idea about the methodology of validation, and
 Rectification of mistakes, if any
6. KNOWLEDGE OF PHARMA WORLD
 Overview of different aspects of market
 Every activity performed provided great deal of knowledge about that topic

Bishwjit Ghoshal_Summer Internship Report 2015

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