FIRM QUESTIONNAIRE E-mail : info@rekrapharm.com Web Site : www.rekrapharm.com Dear Firm Reprsentative, Thank you for getting in touch with us. We have prepared the questionnaire below in order to get to know you better. We aim to understand you better, to have a better idea what kind of firm you are working for, and thus; to be able to provide best possible service to you. In order to determine a good strategy and to be able to produce the right solutions for your benefit, the below questionnaire aims to bring together a proper and right information base about you. All information provided herein will remain completely confidential. Information provided herein will not be disclosed or shared with third parties or persons and will never be sold for eternity. Therefore, please do not hesitate to provide as clear and detailed information as possible. If you deem necessary not to disclose any information at this point, please do not hesitate to print out and use these questions to prepare a basis of a strategic road plan. However, please note that the questions presented below may not suffice to develop proper strategy for your needs because these are guidelines. Please do not hesitate to contact us if the below questions may appear limited. You can leave blank the answers to the questions below, however; please acknowledge that we shall be able to help you as much as we get to know you. ATTENTION PLEASE : THİS QUESTIONNAIRE DOES NOT PURPORT ITSELF IN ANY FORM FOR A CONTRACT OR AN AGREEMENT. THIS IS A QUESTIONNAIRE PREPARED TO LEARN ABOUT THE CLIENT. ALL INFORMATION IN THIS QUESTIONNAIRE IS ENTIRELY AND STRICTLY CONFIDENTIAL AND WILL REMAIN SO! NONE OF THE INFORMATION PROVIDED HERE WILL BE SHARED WITH OR DISCLOSED TO THIRD PARTIES OR PERSONS. THOSE ACTING OTHERWISE SHALL MEET THE STRICTEST PENALTY REQUIRED BY THE LAW. IN SHORT, ALL INFORMATION HERE REMAINS CONFIDENTIAL. Firm Name : Street Address : Mail Box : City/Province and/or State : Country : Telephone Number : Please provide country code or extension if necessary Fax Number : Please provide country code or extension if necessary Person to contact : Title in the Organization : E-mail Address : Cell Phone (with country code please) : Web Site : Please select the appropriate firm type below or give a brief explanation if “Other” is selected: Pharmaceutical Manufactuer    Distributor     Representative Firm     Marketing and Communications    Other. Please explain below :   Please select the most appropriate one below that fit your explanation. Product Information. Which one/s of the below is your firm producing / manufacturing? Active Pharmaceutical Ingredient   Finished Pharmaceutical Product   Chemicals, etc.   Excipients and/or Pharmaceutical formulations   Natural Extracts   How would you characterize your firm if you had to choose one of the below? Generic Pharmaceutical    Innovator Pharmaceutical     Biotechnology / Pharma     Biotechnology / Fod     Biotechnology / Industrial    Nanobiotechnology    In Clinical Trials    Phase I     Phase II    Phase III     Phase IV    Contract Manufacturing Organization     Contract Research Organization     Medical Device      Does your organization possess manufacturing facilities and/or capabilities? (Yes / No) If you answer “Yes”, please select the most appropriate choice from below. Analytical Equipment    Automation & Robotics    Batch Systems /Equipment    Clean Room Equipment    Filling Equipment    Filtration/Separation/Purification    Laboratory Products & Equipments     Packaging Equipments & Supplies    Manufacturing Facilities / Equipments Process Automation and Controls    Process Equipments    Tablet / Capsule Filling machines     RFID Test & Measurement Devices    Validation      Would you please give as much information as possible when answering the questions below? 1. If you would like to add Turkish market to the target market of your product/s, which one of the services would you consider to outsource (ex: registration, intellectual property rights, feasibility analysis, direct investment, entrepreneurial investment, business plan, branch opening, etc.)?   2. Which countries / regions / markets are you currently marketing your products (please give all appropriate answers)?   3. When you consider your products (such as; pharmaceuticals, generics, biopharmaceuticals, green biotechnology products, indsutrial/environmental biotechnology products, nutraceuticals, etc.), do your products in the afore mentioned categories (or others if you prefer to share with us) possess the proper registration dossier appropriately prepared pertaining to the rules and regulations widely accepted in international commerce? Especially, if we had to ask for pharmaceuticals and medical devices, are your current registration dossiers in CTD format? If so, which language or which languages are they ready in?   4. Are you familiar with EMEA registration process and related requirements? Are you familiar with Turkish registration process and related requirements? (The two have similarities but not necessarily share all the same properties).   The following questions about clinical trials are poised to understand which phase of a clinical trial, if any, your company is at in order to establish a better understanding for new and upcoming products. 5. Are you required to conduct clinical trials for your products in your country / in other markets where your products are distributed? If so, have you conducted clinical trials for your products?   6. Have you been required to conduct clinical trials for your products in EU countries? If so, how successful was the outcome? Please elaborate.   7. If none of the above questions are affirmative, are you in the process of conducting clinical trials for your products?   8. Answer the following question if your product is a generic pharmaceutical: Do you have bioequivalence studies conducted for your products? If so, is the end result favorable to suggest strongly that your product is bioequivalent to the innovator product?   9. Are you confident that your product/s does/do not infringe any patent and/or other applicable intellectual property rights?   10. Would your company be interested in co-development of innovative products/services? Does your company have promising ideas which require financial support?   We welcome additional information or thoughts. Please do not hesitate to share with us. Thank you.