Expand your pharma business to Turkey. Licensing, Market Access, Distribution, Business & Corporate Development

1. Expandpharma will be an extension of your
company in Turkey
by working as part of your team and acting on
your behalf
Expand your pharma business to Turkey
www.expandpharma.com
EX PANDPHARMA

2. TURKEY MARKET ENTRY SOLUTIONS
Start licensing now
and take control of
marketing
authorization rights
for your products Gain time to find the
right market entry
method based on
actual or reasonably
foreseeable market
conditions
Polish your market
entry strategy with
deep market
research including
Key Opinion Leaders
survey
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

3. Turkey market entry options and the relevant services offered by Expandpharma
• Setting up an office/legal entity in Turkey with a min. cost
• Market research, competitive analysis and initial sales
forecasting
• Finalizing the registration and market access process for the
chosen products
• Establishing pharmacovigilance system
• Finding and managing vendors when needed (like 3PL,
translation agent, customs agent, financial advisor, contract
pharmacovigilance service provider etc.)
• Working on the project in detail
• Determining and getting in contact with the potential
partners
• Writing a report summarizing capabilities of the potential
partners
• Arranging and conducting on-site visits
• Assisting in contract negotiation with the chosen partner
• Providing guidance during the implementation phase
• Preparation of the report including information about all the
relevant regulations, guidelines and procedures about the
current named patient sales program in Turkey
• Determining the optimum sales price possible and pricing
strategy
• Finding the eligible suppliers if needed
• Consulting on the contract negotiations when needed
TURKEY MARKET ENTRY SOLUTIONS
FOREIGN SUBSIDIARY
ESTABLISHMENT
STRATEGIC
PARTNERSHIPS
NAMED PATIENT SALE
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

4. CORE SERVICES
Expandpharma is your
designated Marketing
Authorization Holder
where you can secure and
sustain the control of
marketing authorizations
before appointing a
distributor or setting up
your own infrastructure
Regulatory Affairs& Market Access
• Regulatory affairs services include regulatory strategy development, post-registration,
market access activities and project management. Expandpharma can act as head of
Regulatory Affairs for start-up companies or provide a ‘virtual’ regulatory department for
small/medium-sized companies.
• Taking control of Marketing Authorizations for your products will give your company
flexibility in creating the distribution system in the county and a significant amount of
negotiation power.
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

5. CORE SERVICES
Regulatory Affairs& Market Access
APPLICATIONS FOR MARKETING AUTHORIZATION APPLICATIONS FOR GMP INSPECTION OF ABROAD PRODUCTION PLANTS
Expandpharma offers services to get your products on the market faster Expandpharma helps to get the GMP certification in a timely and cost
effective way
 Preparation and submission of registration dossiers in eCTD format and according to
country specific requirements
 Preparation and submission of application dossiers for Marketing Authorization Transfer
 Determining the optimum price level for products according to local regulations and
competition in the market
 Preparation and submission of price and reimbursement applications to the respective
authorities
 Preparation and revision of national SPC, PIL and labelling
 Giving advice and assistance for compliance with the local requirements
 Providing information about GMP application requirements, regulations and guidelines
 Preparing application dossier and making submission to the authority on behalf of your
company
 Managing the process of the on-site inspection by the Turkish Ministry auditors
 Finalizing the certification process after the inspection
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

6. You need to see the complete picture of the market before forecasting the
performance of your product in a new market.
 Market understanding
 SWOT analysis
 Competitive landscape
 Pricing and positioning analysis
 Key opinion leaders survey
 Working on the project in detail
 Determining and getting in contact with the potential partners
 Writing a report summarizing capabilities of the potential partners
 Arranging and conducting on-site visits
 Assisting in contract negotiation with the chosen partner
 Providing guidance during the implementation phase
Expandpharma has the knowledge and expertise to support you on the
following key subjects
Expandpharma focuses on the formulation and implementation of business
development strategies
Many collaboration and partnership opportunities available in Turkey like in-
licensing, out-licensing, technology transfer, co-marketing, co-development, contract
development and contract manufacturing.
CORE SERVICES
Market Research& Business Development
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

7. Expandpharma provides presentations, reports and information on the following subjects
Pharmaceutical Market Intelligence
 Regulatory environment, licensing and product lifecycle regulations
and guidelines
 Turkish pharmacovigilance system and regulations
 Pricing system and calculation methods
 Third party service providers
 Pharmaceutical import procedures and customs process
 Prescription management system
 Reimbursement system
 Distribution channels
 Pharmaceutical products logistics
 Prescription management system
 Incentive programs
 Product promotion
CORE SERVICES
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey

8. ABOUT US
Gökçe has more than 18 years of experience in different
areas of pharmaceutical sector.
She worked in a local distributor company as a Business
Development and Regulatory Affairs Manager for seven years
after her Regulatory Affairs Executive experience for about
five years. She dealt with several international companies to
register and launch their products in Turkey, managed
projects from contract negotiations to market access and
worked with many types of products like biological products,
niche generics and medical devices. Her prior experience
also include Sanovel Pharmaceuticals where she worked as
a Q.C. Lab. Analyst.
Gökçe holds MS degree in Pharmacology and a BS degree in
Pharmacy.
Gökçe Eren
Founder/Managing Partner
Bengi Abacıoğlu
Managing Partner
Bengi has more than 20 years of experience in
pharmaceutical sector, in Regulatory Affairs and Quality
Control areas mainly.
She worked in Regulatory Affairs Manager position for about
6 years in an international pharmaceutical company after her
experience as a Regulatory Affairs Associate and Regulatory
Affairs specialist .
She also worked in a local manufacturing company in Turkey
as a Q.C. Lab. Specialist and in Istanbul University as a
Research Assistant.
Bengi holds MS degree in Analytical Chemistry and a BS
degree in Pharmacy .
Emine Uslu
Managing Partner
Emine has 20 years of experience in pharmaceutical industry,
in Regulatory Affairs, R&D and Quality Control areas.
She worked in Regulatory Affairs Manager position for about
eight years. In a local manufacturing company in Turkey.
She also worked in the R&D department of the same
company at Project Group Manager and R&D
specialist positions for twelve years after her experience in
the Quality Control department as Q.C. Lab. Specialist.
Emine holds BS degree in Chemistry..
EX PANDPHARMA CONSULTING
Expand your pharma business to Turkey