Turkey market entry solutions for your pharma business

1. More than just a consultant, 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 CONSULTING

2. Before deciding on the market entry method,
pharmaceutical companies would like to get answers to the following questions:
MARKET ENTRY SOLUTIONS
 What’s the regulatory framework in Turkey relating to
licensing, pharmacovigilance, pricing and reimbursement?
 Which are the most relevant distribution channels?
 How is the competition in the local market for the regarding
product groups and indications?
 What’re the potential partnership opportunities?
EX PANDPHARMA CONSULTING

3. Expandpharma offers answers for such questions. With the answers, the company would be able to decide on several options.
Turkey market entry options and the relevant services offered by Expandpharma are listed below:
• Setting up an office/legal entity 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
• Choosing 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
MARKET ENTRY SOLUTIONS
FOREIGN SUBSIDIARY
ESTABLISHMENT
STRATEGIC
PARTNERSHIPS
NAMED PATIENT
SALE
EX PANDPHARMA CONSULTING

4. CORE SERVICES
Regulatory Affairs
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.
APPLICATIONS FOR MARKETING AUTHORIZATION APPLICATIONS FOR GMP INSPECTION OF ABROAD PRODUCTION PLANTS
Expandpharma offers guidance on the following for your medicines, medical
devices, biotech or consumer products:
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

5. Market Research
You need to see the complete picture of the market before forecasting the
performance of your product in a new market. Sometimes, although a product
has a big market share in other countries, it doesn’t guarantee high sales in
Turkey with the same approach, because of the country specific market
trends, prescription habits, regulations etc.
 Market understanding
 SWOT analysis
 Competitive landscape
 Pricing and Positioning Analysis
 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
Business Development
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
EX PANDPHARMA CONSULTING

6. 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
EX PANDPHARMA CONSULTING
CORE SERVICES

7. ABOUT US
EX PANDPHARMA CONSULTING
Gökçe has more than 15 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 from Marmara
University and a BS degree in Pharmacy from Istanbul
University.
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 Santa Farma Pharmaceuticals as a Regulatory
Affairs Manager for about 6 years after her experience as
a Regulatory Affairs Associate and Regulatory Affairs
specialist in the same company.
She also worked in Sanovel Pharmaceuticals 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 from Istanbul University.
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 Sanovel Pharmaceuticals as a Regulatory
Affairs Manager for about eight years.
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 from Istanbul University.