Pharma Think Tank Business Presentation, V.W95

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Pharma Think Tank Business Presentation, V.W95

  1. 1. Pharma ThinkTank Consulting Business Presentation Buenos Aires, Argentina
  2. 2. THE TEAM
  3. 3. <ul><li>The Team </li></ul><ul><li>“ Pharma ThinkTank is conformed by a team of professionals specialized in the different aspects of the Pharmaceutical Industry and the Health Market, in general. </li></ul><ul><li>Our human group is formed by men and women of diverse academic and professional background, with a proven track of success in the public and private sectors. This crossed-expertise allows us to analyze the problems from different angles, ensuring a final product tested under every light. This is not just a differential treat of our company but a “double-insurance” for our clients, guaranteeing savings in time and money. </li></ul><ul><li>At Pharma ThinkTank we have a commitment to being leaders in service offering original and personalized solutions to fit the necessities of each one of our clients.” </li></ul>
  4. 4. <ul><li>General Director </li></ul><ul><ul><li>Federico Fascetto </li></ul></ul><ul><ul><li>He currently works as Pharma ThinkTank General Director (2008 onwards) </li></ul></ul><ul><ul><li>He held the position of Immunology Sales and Marketing Manager with Abbott Laboratories in charged of products for Rheumatology, Dermatology, Gastro. and Multiple Sclerosis (2006-2007) </li></ul></ul><ul><ul><li>He was appointed Sales Manager for Johnson & Johnson Medical Devices & Diagnostic's Diabetes division after occupying the position of Regional Marketing Manager for the Southern Cone for the same division, where he successfully launched the first TV campaign in the specialty (2002-2005) </li></ul></ul><ul><ul><li>He worked helping to establish a Biotech business incubator in San Francisco, California (2001) </li></ul></ul><ul><ul><li>He was Founder and Manager of Viacom Consumer Products Cono Sur (1998-2000) </li></ul></ul><ul><ul><li>He also occupied the position of Associate with HSBC Investment Banking (1997-1998) </li></ul></ul><ul><ul><li>Federico holds a Master in Business Administration specialized in Finance & Accounting from the University of Rochester, NY (2002) and a Postgraduate Degree in Marketing from Universidad de San Andrés (1998). He also holds a BA in Business Administration from Univ. Torcuato Di Tella (1997) </li></ul></ul><ul><ul><li>Among other extracurricular activities, he has taught several classes of Pharmaceutical Marketing and Loyalty Programs at the UCES´ MBA Program and different after-graduate programs from University of Bs. As. He has been guest-speaker in different events related to the Health Industry </li></ul></ul>
  5. 5. <ul><li>Associate Directors </li></ul><ul><ul><li>Sonia Tarragona </li></ul></ul><ul><ul><li>She currently works as Mundo Sano Foundation General Director (2008 onwards) </li></ul></ul><ul><ul><li>She was Argentina's National Director of Health Economics (2007-2008) </li></ul></ul><ul><ul><li>She worked as Advisor in Drug Policies, Pharmacoeconomy and Pharmaceutical Industry with the National Ministry of Health, and Coordinator of the Strategic Research Unit of the National Ministry of Health (2002-2007) </li></ul></ul><ul><ul><li>She was appointed as National Coordinator of Drug Policies for the MERCOSUR Region (2002-2008) </li></ul></ul><ul><ul><li>She is a member of the Board of the Argentinean Health Economics Association </li></ul></ul><ul><ul><li>Sonia is Dean of the Masters Degree in Pharmaco-Politics from ISALUD University and active Faculty teaching several courses in undergraduates and postgraduates careers at the UNLP Economics and Medical Schools. She is also teaches Financing and Expenditure, Health Economics and Drug Policies at ISALUD University </li></ul></ul><ul><ul><li>Is author of three books and several articles specialized in the pharmaceutical industry, drug policies, financing, pharmacoeconomics and intellectual property </li></ul></ul><ul><ul><li>Sonia holds a BA in Economics and a Masters Degree in Public, Provincial and Municipal Finance from the UNLP. She is a Health Economics, Pharmaceutical Industry and Public Service Regulations Specialist from UADE University. </li></ul></ul><ul><ul><li>She has served as guest-speaker in numerous national and international congresses and has represented Argentina in several Governmental Forums in relation to R&D, Innovation, IP and Public Health </li></ul></ul>
  6. 6. <ul><li>Associate Directors </li></ul><ul><ul><li>Gerardo Carchio </li></ul></ul><ul><ul><li>He currently works as General Director DOC/HR Solutions and as a free-lance Consultant for Korn Ferry International (2007 onwards) </li></ul></ul><ul><ul><li>He worked as Regional Director of Human Resources with Johnson & Johnson Medical Devices & Diagnostics for the Southern Cone and as HR Business Partner for LifeScan J&J division for Latin America (1996-2006) </li></ul></ul><ul><ul><li>He worked as independent Psychologist and Organizational Development Consultant (1981-1995) </li></ul></ul><ul><ul><li>He held a number of Sales positions over the years. He headed regional sales teams for companies such as Noblex and Hitachi (1978-1981), and a local team for Renault Group (1977-1978) </li></ul></ul><ul><ul><li>Gerardo currently is an active Faculty teaching Managerial Skills and Administration and Change Management at the Masters in Business Administration Program from UCEMA. He is also a frequent guest-speaker at IAE's Business School in topics related Leadership and Organizational Development </li></ul></ul><ul><ul><li>He holds a BA in Psychology from Universidad de Belgrano. He has a Masters Degree in Diagnostic Techniques and Organization Change from the same University and another Masters Degree in Businesses Administration from CEMA. Additionally, he has completed a Program in Executive Education at IAE University and a Program in Executive HR Development at Michigan University </li></ul></ul><ul><ul><li>Gerardo is an independent author of dozens of articles related to Coaching, Leadership and Organizational Development </li></ul></ul>
  7. 7. <ul><li>Associate Directors </li></ul><ul><ul><li>Eduardo Cioppi </li></ul></ul><ul><ul><li>He was Regional Manager for Asia, Africa and Europe for Laboratorios Bagó S.A. (2006-2008) </li></ul></ul><ul><ul><li>He held the positions of Quality Control Manager for Laboratorios Bagó S.A. (1998-2006) and Quality Engineering Manager for Abbott Laboratories Argentina (1995-1998) </li></ul></ul><ul><ul><li>He was Head of the Analytical Laboratory of Ciba Geigy (today Novartis) from 1992 until 1995 </li></ul></ul><ul><ul><li>Eduardo has specialized in quality and regulatory affairs throughout the majority of his professional career. In the past few years, however, he was appointed to occupy regional positions in the commercial area. This multinational exposure left him with vast knowledge of the pharmaceutical business in different regions of the world. Among other things, he became an expert in the development of business models for the registry, distribution and commercialization of pharmaceutical products in different countries of Asia, Africa and Europe </li></ul></ul><ul><ul><li>In early stages of his career, Eduardo was a an active faculty teaching Analytical Chemistry at the Department of Inorganic, Analytic and Physic Chemistry from the University of Buenos Aires </li></ul></ul><ul><ul><li>Eduardo holds a BA in Chemistry also from Universidad de Buenos Aires and has a Masters Degree in Industrial Enterprise Management from UCA-EOI (Madrid) and a Diploma in Project Management (PMI) from the Instituto Tecnológico de Buenos Aires (ITBA) </li></ul></ul><ul><ul><li>Additionally, he has completed several courses at Instituto Argentino de la Empresa (IAE) in Management and Human Resources, on top of several others in Quality Affairs and Pharmaceutical documentation in Chicago, USA. He has also taken courses in Marketing and Neuro-Linguistic Programming </li></ul></ul>
  8. 8. <ul><li>The Company </li></ul>
  9. 9. <ul><li>Mission </li></ul><ul><li>“ Our objective is to be the consulting firm leader in service in each one of the markets in which we decide to operate. Our expertise is mainly concentrated on the areas of Pharmacoeconomy, Legal, Regulatory, Commercial and Human Resources. Our success rests upon the fundamental premise of being able to satisfy with excellence the needs of our clients, Pharmaceutical Companies, CROs, Research Centers, Medical Associations and Government Agencies, based on four fundamental pillars of service: Agility, Reliability, Flexibility and Seriousness.” </li></ul>
  10. 10. <ul><li>V isi o n </li></ul><ul><li>“ We see Pharma ThinkTank as a legitimate way of adding value to the society in which we live in and operate on. We view it as a source of ideas and strategic/operative solutions at the benefit of Pharmaceutical Companies and the Healthcare industry, in general. </li></ul><ul><li>As a group of professionals we share a common passion for consulting services and for personalized attention to our clients. We are keen to the use of technology and the most modern research and marketing tools. We seek to reduce bureaucracy to the minimum and to maximize growth opportunities. We strive permanently to administer resources efficiently and for excellence in everything we do. </li></ul><ul><li>We want to be picked for and distinguished by the excellence of our service. We want our workers and providers to be proud and satisfied of working with us, recognizing us as fair and honest counterparts with whom to create long-term alliances with. </li></ul><ul><li>We desire to be recognized for our social engagement, for taking part and collaborating with different projects involving the communities in which we operate on . </li></ul><ul><li>Finally, we establish ethics as our company’s corner stone . It will be this and no other, who will prevail together with common sense , in every single decision-making process.” </li></ul>
  11. 11. <ul><li>Values </li></ul><ul><ul><li>Ethics and common sense, above all, as ultimate guiders of our personal and professional conduct. Present in every decision-making process. </li></ul></ul><ul><ul><li>Maximum confidentiality , in dealing with our clients’ information. </li></ul></ul><ul><ul><li>Equity , responsibility and transparency , in each transaction, activity, or potential or actual relation. </li></ul></ul><ul><ul><li>Empathy, to understand the problem from the client’s perspective and to look for the optimum solution in an objective manner. </li></ul></ul><ul><ul><li>Energy and positivism, as a general attitude to achieve every desired objective and milestone, no matter how hard or unreachable it may seem a priori . </li></ul></ul>
  12. 12. <ul><li>Business description </li></ul><ul><ul><li>Current and potential clients </li></ul></ul>Pharma TT Medical Associations Public and Private HMOs Clinical Research Centers CROs Pharmaceutical Companies Government Agencies
  13. 13. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>Pharma TT <ul><li>REGULATORY </li></ul><ul><li>Agency services </li></ul><ul><ul><li>Permits </li></ul></ul><ul><ul><li>Registrations </li></ul></ul><ul><li>Advisory and Auditing Services </li></ul><ul><ul><li>Good Practices Certifications </li></ul></ul><ul><ul><li>Clinical Research </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Market Research </li></ul><ul><li>Development of Launching </li></ul><ul><li>and Product Positioning Strategies </li></ul><ul><li>Congresses and Events </li></ul><ul><li>Courses and Training on </li></ul><ul><li>“ The Argentinean Health System” </li></ul><ul><li>Workshops in Intellectual Property </li></ul><ul><li>Legal support in commercial operations </li></ul><ul><li>LEGAL </li></ul><ul><li>Consulting Services </li></ul><ul><ul><li>To Law Firms / legal divisions </li></ul></ul><ul><ul><li>To commercial divisions </li></ul></ul><ul><ul><li>To Labor Union and Private HMOs </li></ul></ul><ul><ul><li>To Pharmacies and other institutions </li></ul></ul><ul><li>PHARMACOECONOMICS </li></ul><ul><li>Vis-à-vis studies drugs vs. other treatments </li></ul><ul><li>Pharmaceutical-cost indicators </li></ul><ul><li>Economic valuation-tools of drug usage </li></ul><ul><li>Training and Workshops on Pharmaco- </li></ul><ul><li>economy </li></ul><ul><li>HUMAN RESOURCES </li></ul><ul><li>Leadership Modules </li></ul><ul><li>Recruiting & Head-hunting </li></ul><ul><li>OTHER SERVICES </li></ul><ul><li>Strategic Disembarking </li></ul><ul><li>Partnering </li></ul>
  14. 14. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>PHARMACOECONOMY
  15. 15. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>PHARMACOECONOMY </li></ul><ul><li>Pharmaceutical cost indicators </li></ul><ul><li>Identification, classification, analysis and determination of economic costs </li></ul><ul><li>Estimation of new products costs </li></ul><ul><li>Temporary adjustment of costs and sensibility analysis </li></ul><ul><li>Monetary valuation of resources utilized in the application of a new product </li></ul><ul><li>Supporting techniques for economic valuation </li></ul>
  16. 16. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>PHARMACOECONOMY </li></ul><ul><li>Vis-à-vis studies of drugs, treatments and medical technology </li></ul><ul><li>Evaluation of a new product vs. reference product/treatment (“Golden Standard”) </li></ul><ul><li>Evaluation of a new product vs. existing product </li></ul><ul><li>Evaluation of a new product vs. placebo </li></ul><ul><li>Evaluation of costs of a new product </li></ul>
  17. 17. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>PHARMACOECONOMY </li></ul><ul><li>Planning of studies and economic valuations </li></ul><ul><li>Development of Cost Minimization Studies (CMS) and Cost-Effectiveness Studies (CES) . Analysis and application of results in the decision-making process, economic valuation and policy of drugs </li></ul><ul><li>Development of Cost-Utility Studies (CUS), estimation of benefits of diverse treatment alternatives. Usage and calculation of quality adjusted life-years (QALY) . </li></ul><ul><li>Development of Cost-Benefit Studies (CBS) . Monetary valuation of results, development of a measure of monetary value and valuation of results through willingness to pay </li></ul>
  18. 18. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>PHARMACOECONOMY </li></ul><ul><li>Executive education and training in pharmacoeconomics </li></ul><ul><li>Courses and seminars in pharmacoeconomics, economic valuation and analysis of results </li></ul><ul><li>Elaboration of articles and statistical analysis </li></ul>
  19. 19. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>LEGAL
  20. 20. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>LEGAL </li></ul><ul><li>Advisory to Law Firms / legal departments or divisions </li></ul><ul><li>Our deep understanding of the Health Industry allows us to successfully advice Law Firms and a broad array of legal departments/divisions of players related to the industry </li></ul><ul><li>Among other topics, general legal framework and specific norms about the National System of Health Insurance, PMO (Mandatory Medical Plan), national and international legislation on Disability, Decentralized Operations Regime for Public Hospitals </li></ul><ul><li>Goodwill acquisition </li></ul><ul><li>Specific legislation on the different aspects and actors of National and Provincial sanitary policy </li></ul>
  21. 21. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>LEGAL </li></ul><ul><li>Advisory to commercial divisions </li></ul><ul><li>We offer legal support to commercial divisions of pharmaceutical companies, drug-wholesalers, and other drugs and medical devices distributors </li></ul><ul><li>Drafting and/or review of existing provision and distribution contracts, among others </li></ul><ul><li>Advisory on current ANMAT (Argentinean Food and Drug Administration Agency) legislation , Special Programs Administration (or “APE”, in Spanish), Superintendence of Health Services and the Federal Health Program </li></ul>
  22. 22. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>LEGAL </li></ul><ul><li>Advisory to commercial divisions (cont.) </li></ul><ul><li>Legal support in topics related to Business Loyalty according to Law 22,802 </li></ul><ul><li>Preventive legal analysis of advertisements, games and promotions </li></ul><ul><li>Advisory on Customer Defense issues related to administrative and judicial claims </li></ul><ul><li>Evaluation of alternatives before administrative fines in relation to the application of Commercial Loyalty laws, Customer Defense, legal and supply metrology, with vast knowledge of the criteria followed by the corresponding National, Provincial and of the Government of the City of Buenos Aires authorities </li></ul><ul><li>Analysis and recommendation related to the convenience of appealing to the Arbitration Court of Consumption </li></ul>
  23. 23. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>LEGAL </li></ul><ul><li>Advisory to Labor Union and Private HMOs </li></ul><ul><li>General judicial framework and specific norms and regulations on the National System of Health Insurance, PMO (Mandatory Medical Plan), national and international legislation on Disability </li></ul><ul><li>Special Programs Administration (APE): Current legislation. Coverage: Medical assistance services. Drugs and treatments. Basic mandatory services for disabled people. Procedure for presentation of financial support forms. Exception ways. Reference values </li></ul><ul><li>Superintendence of Health Services: Judicial ordering. National Registry of Care Providers. Decentralized Operations Regime for Public Hospitals: Fees and approved practices per category. Formulary. Automatic debit system </li></ul>
  24. 24. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>LEGAL </li></ul><ul><li>Advisory to Pharmacies and other institutions </li></ul><ul><li>Our company specializes also in topics related to obtaining permits for pharmacies, drug-wholesalers, medical establishments, among others </li></ul><ul><li>Advisory on drug coverage by the National System of Health Insurance, whether be it ambulatory or for special treatments/pathologies. Alternative therapeutic drugs. Drugs with 100% coverage for beneficiaries </li></ul><ul><li>Drafting or revision of provision contracts, distribution, management and/or administration of pharmacies </li></ul><ul><li>National Registry of Care Providers: professionals, establishments and network of pharmaceutical services </li></ul>
  25. 25. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>COMMERCIAL
  26. 26. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Market Research </li></ul><ul><li>Our organization counts with the support from experts in the market research field with broad experience in projects related to launching, positioning or repositioning pharmaceutical products and medical devices at a local and regional level (Latin America) </li></ul><ul><li>The different methods include background research or secondary data, qualitative and quantitative research, motivational and experimental research. Within the latter we can distinguish the exploratory, conclusive and performance monitoring </li></ul><ul><li>Among the techniques applied to research we can distinguish personal, phone or on-line interviews to physicians, end-consumers and/or purchase decision-makers, focus groups, multi-target groups and “mystery shopper” technique </li></ul>
  27. 27. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Launching and product-positioning strategies </li></ul><ul><li>We specialize in generating ideas for launching new products, uses, pharmaceutical forms and indications before the most diverse audiences including prescribing physicians, KOLs, medical-auditors, pharmacy personnel, Government agencies personnel, and patient associations and their families (only for OTC products) </li></ul><ul><li>Our services range from external logistics and/or organizational assistance to Commercial Divisions to delivering “turnkey projects” that include, among other things, audio services, lighting, simultaneous translation (to virtually every language), photography, video, catering, and transportation and hotel accommodations for events inside and outside national territory </li></ul>
  28. 28. <ul><li>Business description </li></ul><ul><li>COMMERCIAL </li></ul><ul><li>Development of Overseas Markets </li></ul><ul><li>• We offer consulting and advisory services for the development, registry and commercialization of pharmaceutical products in Southeast Asia, MENA (Middle East and North Africa), Africa and Europe. </li></ul><ul><li>• We have proven expertise in markets such as: </li></ul><ul><ul><li>ASIA: Pakistan, Sri Lanka, Myanmar, Vietnam, Singapore, Malaysia, Indonesia, China, Thailand, Korea and Philippines </li></ul></ul><ul><ul><li>MENA: Lebanon, Morocco, Jordan, GCC, Egypt, Iran and Yemen </li></ul></ul><ul><ul><li>Africa: Kenya, Sudan, Ivory Coast, Benin, Congo, Senegal, Togo, Cameroon and South Africa </li></ul></ul><ul><ul><li>Easter Europe: Russia, Ukraine, Kazajstan, Georgia, Azerbaijan, Armenia, Croatia </li></ul></ul><ul><ul><li>Central Europe </li></ul></ul><ul><ul><li>Service Areas </li></ul></ul>
  29. 29. <ul><li>Business description </li></ul>COMMERCIAL Development of Overseas Markets (cont.) • Each country presents its own business model, regulatory barriers, standard procedures for registering products and brand and fixating prices. They also have their own traditional commercial channels, reimbursement programs and tendering processes • Each country represents a different business opportunity according to the therapeutic class and products chosen <ul><ul><li>Service Areas </li></ul></ul>
  30. 30. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Courses and workshops on aspects of “The Argentinean Health-System” </li></ul><ul><li>Design and general organization (“turnkey projects”) of internal training courses aimed at upper/middle management, as well at general personnel </li></ul><ul><li>Design, recruiting and general organization (“turnkey projects”) of external training courses , aimed at physicians, auditors, pharmacy and HMO personnel, and/or at Government authorities. </li></ul><ul><li>Topics include differences between the public and private sectors , including general procedures and legal ordering, the National System of Health Insurance, structure and functioning of the Special Programs Office (APE), Mandatory Medical Program (PMO), National Administration of Pharmaceutical Companies and Health Institutes (ANLIS), Federal Programs, and every aspect related to special treatments and drug-pharmacoeconomics, among others. </li></ul>
  31. 31. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Workshops in Intellectual Property </li></ul><ul><li>Introduction to the concept of Intellectual Property (Patents) </li></ul><ul><li>Advantages and disadvantages of its application from a commercial standpoint </li></ul><ul><li>International treaties and their implication in the pharmaceutical business </li></ul><ul><li>Current situation in Argentina </li></ul>
  32. 32. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>COMMERCIAL </li></ul><ul><li>Advisory to commercial divisions </li></ul><ul><li>We offer legal support to commercial divisions of pharmaceutical companies, drug-wholesalers, and other drugs and medical devices distributors </li></ul><ul><li>Drafting and/or review of existing provision and distribution contracts, among others </li></ul><ul><li>Advisory on current ANMAT (Argentinean Food and Drug Administration Agency) legislation , Special Programs Administration (or “APE”, in Spanish), Superintendence of Health Services and the Federal Health Program </li></ul>
  33. 33. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>HUMAN RESOURCES
  34. 34. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>HUMAN RESOURCES </li></ul><ul><li>Leadership modules </li></ul><ul><li>Design and organization of workshops on leadership, motivation and managerial coaching specially tailored for executives whose main responsibility is conducting technical and/or commercial teams. Led by publicly-recognized figures in the field, these workshops emphasize on solving problems and conflicts with a lateral approach (“out of the box thinking”), in which all parts included win while none lose (“win-win agreements”) </li></ul>
  35. 35. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>HUMAN RESOURCES </li></ul><ul><li>Recruiting & Head-hunting </li></ul><ul><li>We count with a division specifically oriented to satisfying the demand of our clients for executives oriented to the health-industry. Our expertise lays mainly on searches aimed at upper and middle managers/executives </li></ul><ul><li>We specialize in reengineering and general consulting services on Human Resources, including the analysis and development of career plans based on core-competencies, succession planning, compensation schemes, and searching, retaining and developing internal talent within the organization </li></ul>
  36. 36. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>REGULATORY
  37. 37. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Agency services: Registrations </li></ul><ul><li>We register medical specialties, medical products/devices, pharmaceutical products registered and elaborated in a member-state of MERCOSUR. </li></ul><ul><li>We also register sworn declarations after Label changes (Disp. 3855/98), identification characteristic data and new pharmaceutical form and concentration </li></ul>
  38. 38. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Agency services: Registrations (cont.) </li></ul><ul><li>We advice on and take care of inspection requests to manufacturing plants from abroad, registration of medical products, registration of diagnostic products of “in vivo” usage, bioequivalence formularies (5040/06), formularies for importing medical products, declarations of change of Medical Director (Disp. Nº 2319/02), requests for alimentary-products analysis, registration of alimentary products and dietary supplements (RNPA), authorization for bottles and other materials in contact with food, forms for free-circulation with alimentary-products, forms for free-circulation with bottles and other materials in contact with food </li></ul>
  39. 39. <ul><li>Business description </li></ul><ul><li>REGULATORY </li></ul><ul><li>Advisory Services: Production of Dossiers </li></ul><ul><li>We provide assistance in the production of Dossiers in spanish for the registry of products in countries of Latin America, as well as Dossiers in english for the registry of products in countries of Asia, MENA (Middle East & North Africa), Africa and Europe in accordance to the current norms and regulations of the country. We also assist our clients during the registry process itself advising them and dealing directly with the regulatory authorities of each country. </li></ul><ul><ul><li>Service Areas </li></ul></ul>
  40. 40. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Advisory and auditing services: Certification in Good Practices </li></ul><ul><li>Our crew of experts offer advisory in everything related to obtaining certification for GMP / GCP / GLP, GMP for plants, GMP for products exclusively made for export, GMP for product-registry abroad, certification of lots clearance for pharmaceutical products made for export, certification of OTC sale, certification of pharmaceutical products according to WHO model and GMP certification for export of raw materials </li></ul>
  41. 41. <ul><li>Business description </li></ul><ul><li>REGULATORY </li></ul><ul><li>Advisory and auditing services: Certification in Good Practices (cont.) </li></ul><ul><li>We provide assistance in the prior stages of being audited or inspected by foreign authorities of Latin-American countries or of regions such as Asia, Middle East, Africa and Europe. We issue improvement recommendations and layout action plans to prepare the plant for the inspections. At the same time we stand by our clients and advice them throughout the entire auditing process with the final goal of getting approval in accordance to the actual norms and regulations of the country conducting the inspection. </li></ul><ul><ul><li>Service Areas </li></ul></ul>
  42. 42. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Advisory and auditing services: Clinical Research </li></ul><ul><li>We offer a comprehensive list of services targeted to the sponsors of Clinical Research studies. These include, among others, the co-design an drafting of protocols for the different phases of the study, advisory in the preparation and presentation of documents before regulatory authorities, internal auditing, systems and processes, selection and independent auditing to Research Centers, contingency-plan development and monitors training </li></ul><ul><li>We also offer complete methodological support and advisory to Ethic Committees </li></ul>
  43. 43. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Other agency services </li></ul><ul><li>We assist our clients in obtaining permits and completing paperwork related to the opening and/or regularization of pharmaceutical companies, laboratories specialized in clinical analysis, drug-stores, pharmacies, physician offices, medical centers, clinics, sanatoriums, institutes and maternity clinics, orthopedic shops, optics shops, herbal shops, vaccination offices and distributors of biomedical, sterile and disposable products in accordance to Resolution N° 255/94 </li></ul>
  44. 44. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>REGULATORY </li></ul><ul><li>Other agency services (cont.) </li></ul><ul><li>We also help our clients obtain permits to import, export, elaborate medical-specialties, handle active principles, establish manufacturing and bottling facilities, resellers and importers of fitotherapeutic drugs, permits to drug-distributing companies, permits for bottling, reselling and warehousing companies of Ethylic Alcohol destined for humane use, registry of establishments that do interjurisdictional transit, permits of manufacturing and importing establishments of medical products, and registry of establishments and dietary and supplementary products </li></ul>
  45. 45. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul>OTHER SERVICES
  46. 46. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>OTHER SERVICES </li></ul><ul><li>Strategic Disembarking </li></ul><ul><li>Our company offers a unique 360º advisory service aimed at satisfying the needs of those looking to establish temporary or permanently in Argentina </li></ul><ul><li>Our multidisciplinary team ensures the most comprehensive coverage available in the market in issues related to Legal, Regulatory, Commercial, Pharmacoeconomy and Human Resources </li></ul><ul><li>Thanks to exclusive strategic alliances we also offer our clients Real State (plants, warehouses, commercial offices) and Financial advisory </li></ul>
  47. 47. <ul><li>Business description </li></ul><ul><ul><li>Service Areas </li></ul></ul><ul><li>OTHER SERVICES </li></ul><ul><li>Partnering/Licensing </li></ul><ul><li>Strategic partnering search in the local and international market for the marketing of medical devices and/or pharmaceutical products according to the company profile, line of products and desired level of financial exposure </li></ul>
  48. 48. Sales Contact Federico Fascetto [email_address] Cell. (from within Argentina): 155 182-5232 Cell. (from Abroad): +(54911) 5182-5232 Other Inquiries Attn: Consulting Team [email_address] Phone/Fax (from within Argentina): 011 4778-0301 Phone/Fax (from Abroad): +5411 4778-0301 Pharma ThinkTank Consulting Av. Pueyrredón 1194, 7º piso 25 Ciudad Autónoma de Buenos Aires (C1118AAB), Argentina

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