�ݺ�ߣ

1. INTERNATIONAL MARKET DEVELOPMENTVACCINES ,BIOLOGICS, SPECIALTY PHARMA, GENERICS, HOSPITAL SUPPLIES & DIAGNOSTICSAmbianceVentures

2. OUR CAPABILITIES IN GLOBAL MARKETSGOVERNMENT (Public) MARKETSPRIVATE MARKETSAmbianceVentures

3. International Distribution: Summary of ServicesRegulatory• Logistics: Customs, Warehousing & Cold Chain Storage• Local Order Processing• Collection, Accounts Receivables• Credit & Risk Management• Government and Private Sales• Repackaging & Labeling• Delivery & Transportation• Reverse Logistics – Returns, handling expired, obsolete product• Cross Docking• Sample Management

4. Pharmacovigilance – Follow-up and tracking

5. Bridging studies – Follow-upAmbianceVentures

6. Qualifications:‘Approved’ / ‘Accredited’ / ‘Preferred Distributor’ ‘Govt. Authorized Agent’‘Clearing & Forwarding Agent’‘Warehousing Agent’ Endorsement from Ministry of Health – ‘local’ bidders are preferred

7. Accredited bidders – Principal-to-Agent Agreement

8. Comply with paperwork for government tenders

9. Physical presence required during bid opening process

10. Negotiate bidding prices – 1 cent difference in price can win or lose tender!

11. Consolidation of local orders for differed deliveries, drop shipments.

12. Multiple agents for govt. bids, private markets , institutional markets

13. Staffing: 5 to 10 people specialized in customs , regulatory, tenders, logistics and other business functions. Ward off competitors’ efforts for bids through counterproposalsAmbianceVentures

14. REGULATORY & LEGAL COMPLIANCE:Filing initial application for Product Registration

15. Obtain required certification, licenses

16. Follow-up on application through multiple agencies

17. Submit samples, submit analytical, BE studies and clinical reports

18. Initiate bridging studies, periodic stability tests done locally (follow-up and coordinate)Prepare dossiers per country laws

19. Registration with ‘local government’ (state / province)

20. Registration for private distribution in ‘cooperatives’AmbianceVentures

21. REGULATORY & LEGAL COMPLIANCE:Labeling requirements; Local / regional language translation

22. Periodic follow-up (weekly)

23. Most Governments DO NOT OPEN Letters of Credit

24. Customs documentation is CRITICAL

25. Comply with specified product delivery criteria

26. INCOMPLETE OR INACCURATE DOCUMENTATION CAN RESULT IN INORDINATE DELAYS IN PRODUCT LAUNCH, OR OUTRIGHT REJECTION

27. Delays in product delivery and improper storage at govt. appointed facilities can result in damage, loss of potency , product obsolescence – write off, returned product and additional cost for disposal or reverse logisticsAmbianceVentures

28. PRIVATE MARKETS:Influential in lobbying Federal and Provincial Governments, Regional DistributorsAgent / Distributor plays a crucial role

29. Reputation in private market supply chain

30. Supply logistics, cold chain, customer service

31. Institutional : Large insurance companies, Hospital chains

32. Retail: Pharmacy chains

33. Wholesalers: Physician offices

34. National level programs through private clinics

35. Create Local Advisory Boards; Strong connections with KOLsAmbianceVentures

36. ACCOUNTS RECEIVABLES, COLLECTIONS:Governments do not open Letters of Credit

37. Terms vary from 90 – 180 days credit

38. Sometimes bank guarantees can be obtained.

39. Assuming the Financial Risk - Agents / Distributors are experienced in collections from both government and private buyersPrivate and institutional buyers want 90 – 120 days creditAmbianceVentures

40. LOGISTICS:Customs clearance – proper documentation

41. Receiving shipments, ensuring cold-chain at port / airport

42. Deal with port authority, associated bureaucrats and labor unions

43. Reduce risk of product damage and obsolescence

44. Freight consolidation – in-bound and out-bound

45. Re-packaging, re-dressing or special labeling in controlled environment

46. Storage permits and licenses

47. Cold chain validation

48. Proof of delivery procedures

49. Documentation:

50. Packaging list, Invoice, CoA, Customs Duty,

51. Point to point delivery: inland distribution to multiple final destinations

52. Return of expired, damaged or defective product

53. Disposal of expired, damaged or defective productAmbianceVentures

54. PHARMACOVIGILANCE:While an agent or distributor does not undertake fulltime PV responsibility,they are the first responders within their specific region or country for AE’s and SAE’s Collecting defective product

55. Contacting reporting medical facility for liaison

56. Product recalls when necessary

57. Submit samples of ‘defective’ product to authorized labs.

58. Destruction of returned product if necessaryAmbianceVentures

59. Operational Objectives & Methodology:(1) Discover: Data collection pertinent to Clients’ needs(2) Diagnose: Analyze data and information to arrive at a cost-effective international strategy(3) Design: Design the solution through application of strategy - a plan / proposal(4) Deliver: Implement the solution through appropriate sales tactics.APPROACH:Capabilities presentation to examine opportunities to market vaccine products in select global markets in accordance with your strategy.Identify potential partners / distributors for import of finished products or bulk vaccine for stockpile or re-distribution to private and public buyers in foreign markets

60. Design a step approach for future marketing needs in international markets.AmbianceVentures

61. Our Operations in IndiaPrincipal Role: International Logistics & DistributionExports & ImportsFreight ConsolidationCustoms Documentation & ClearanceProduct RegistrationRegulatory FilingsBridging Studies, Bioequivalence StudiesStorage, Warehousing, Cold Chain Distribution.Dependable source for Biologics, Pharmaceuticals, Diagnostic Products and Hospital SuppliesAmbianceVentures USA

62. INTRODUCTION: How we handle global businessPennsylvania (USA) & Mumbai (India) based Global Business Development company with offices and operations in United States, United Kingdom, Philippines, Dubai and Affiliates in China. Specialized in International Business Development and Exports of Life Science products – Vaccines, Generics, Biologics, Diagnostics, and pharmaceutical machinery End-to-end solution for:Formulation, Analytical Development

63. Export APIs, Finished Products, POC / In-vitro Diagnostics

64. Contract Manufacture

65. Neutral Label & Private Label Manufacture

66. Global Marketing Assistance

67. Complete Export Documentation – Registration, Customs, RegulatoryAmbianceVentures USA

68. GLOBAL MARKETING, TRADE & BUSINESS STRATEGYWe market in the following countries:North America: United States, Canada, MexicoEuropean Union: United Kingdom, Germany, Italy, Russia, Bulgaria, Hungary, Portugal, Spain, IrelandLatin America / Central America:Argentina, Brazil, Chile, Bolivia, Peru, Panama, Caribbean Is., Guyana, Surinam, ColombiaAsia, West Asia & Pacific: Afghanistan, Bangladesh, Bhutan, Cambodia, China, Indonesia, Iran, Iraq, Jordan, Middle East Nations, Malaysia, Philippines, Sri Lanka, Taiwan, Turkey, VietnamAfrica:Cameroons, Congo, Egypt, Ghana, Kenya, Libya, Mauritius, Morocco, Sudan, South Africa, Uganda, ZambiaCIS Countries:Ukraine, Russia, Kazakhstan, Uzbekistan, Armenia, TajikistanAmbianceVentures USA

69. We Specialize in International Marketing:Diversity of Our Product Range:Branded and Generic Pharmaceuticals, Biologics, Biogenerics,

70. including Private Label, Neutral Label, Govt. Label

71. Biologics – Adult & Pediatric Vaccines, Sera and Anti-venoms

72. Our current focus: H1N1 (Swine Flu) Vaccine, Seasonal Flu Vaccine.

73. Hospital Supplies – Private Label and Generic

74. Pharmaceutical Ingredients: APIs, Empty Capsules, Excipients,

75. Fine Chemicals, Intermediates

76. Lab Supplies: Instrumentation, Reagents and Chemicals

77. Dental Products and supplies

78. Packaging Materials: Vials, Ampoules, Bottles, Blister packs, Aluminum Foils

79. Diagnostic Tests and Devices: HIV, Pregnancy, Diabetes, Malaria, STDs,

80. OTC and Personal Care Products – Branded, Generic and Private Label –

81. Custom manufactured at our own facilities in Dubai Tax Free Zone or IndiaAmbianceVentures USA

82. Outsource your Export Marketing, Regulatory and Customs formalities to us:We have an established and reliable Worldwide infrastructure for Marketing and logistically sound Distribution, capable of handling large or small volumes.Deep contacts and superior reputation within Governments andPrivate Markets resulting from 28 years of international business dealingsDependable Agents / Distributors across all continents who will pro-activelypromote your products to focused target segments, Ministries of Health andnon-governmental entities at Federal, Provincial and Local levelsThe Best of Logistics in terms of Warehousing, Cold Chain for timely deliveries.Expertise in Shipping, Scheduling, Consolidation for FCL shipments, Optimaluse of container space, Economical and timely Routing, Freight Insurance.World-class Air and Sea Connections Efficient Customs handling including pre-shipment inspections of product, packaging, labeling, shipping marksAmbianceVentures USA

83. Former President of India – Dr. A.P.J. Kalam, and the Hon. President of the Philippines – Gloria Macapagal Arroyo preside over signing of agreement with Valerian Lobo (Feb 2006)LOB International was appointed ‘Authorized Sourcing Agent’ by The Philippines Ministry of Health for supply of Pharmaceuticals, Biologics and Hospital supplies from India AmbianceVentures USA

84. Advantage – Ambiance Ventures: U.S. OperationsBy partnering with us, as a local producer, you will dominate with low prices, efficient logistics and production capabilities.

85. NEWEST PRODUCTS & FORMULATIONS – Far Superior to existing players!

86. Marketing of biopharmaceuticals to Government & Private markets

87. Rapid formulation, development and commercialization per US FDA standards

88. Client will own the Intellectual Property for formulation, development and manufacture.

89. Leverage local know-how in India to deal with bureaucracy and the government

90. Enjoy benefits of local manufacture and exports to other countries

91. Import finished products in Generics, Diagnostics and APIsAmbianceVentures USA

92. OTHER SERVICES in Life sciences fromOur US Office:Strategic Consulting & Market Development ServicesClient Profile:Biotechnology, Pharmaceutical, Medical Device and HealthcareCompanies in US, Canada, Latin America, India & China.Areas of Expertise:Contract ManufactureBulk Drugs, API ImportsGeneric Drug Formulation, Development & ValidationAlliance Management: Identify partners, Due Diligence, Venture CapitalCountry Representation: US, India, Latin America, EuropeMedical Conventions, Trade Shows, Speakership, Advisory BoardsStrategic Marketing, New Product CommercializationOutsource Clinical Trial Design, Site Management, BA/BE StudiesThought Leader Development, Business IntelligenceExpertise in multiple therapeutic areasAmbianceVentures USA

93. CONTRACT MANUFACTURE – Why Outsource your Contract Manufacture to us in India?Reduce capital expenditure and costs of manufacturing operations

94. Generic substitution, LOW COST, HIGH QUALITY, TIMELY PRODUCTION

95. Need to access specialized, economical mfg technology and methods

96. Have alternate mfg. sources in the event of supply interruptions

97. Unforeseen increase in demand

98. One-stop-shop for all PHARMA products and diagnostics needs

99. Our 28-year experience in sourcing for generics, contract mfr, combined with buying power in India, China, Thailand, and other promising supply sources globally. AmbianceVentures USA

100. Our Contract Partners offer following STANDARDS OF MANUFACTURE & REGULATORY COMPLIANCE:ISO 9001

101. ISO 13485

102. cGMP

103. ANVISA (Brazil)

104. FDA (United States)

105. EMEA (European Union)

106. SAHRPA (South Africa)

107. ANMAT (Argentina)AmbianceVentures USA

108. Popular Categories of products exported globally through our offices:Anti-retrovirals (HIV, AIDS), Anti-Virals (Oseltamivir, Zanamivir)

109. Anti-TB cocktails

110. Anti-Malaria cocktails

111. Biogenerics for Cancer

112. Cardiovascular

113. Antibacterials

114. Immunosuppressants

115. Hormonal, Infertility

116. Erectile Dysfunction

117. Sclerosants

118. Mucolytic agents

119. Anti-pyretics

120. Cough and Cold

121. Pediatric & Adult Vaccines

122. H1N1 (Swine Flu) Vaccine-2010-11 SeasonAmbianceVentures USA

123. DISTRIBUTION & PRICING STRUCTURE“Right products at the right price, within your quality specs”Primary Consumption, Secondary Distribution

124. Specialists in Government Contracts, Private Market

125. Drop shipments

126. All Customs and Shipping Documentation

127. Labeling (in any language)Pricing Variants:Name of Product (if branded) or Generic Name

128. Indication

129. Chemical name or composition

130. Form of Product (tablet, capsule, liquid, gel, powder) / Bulk

131. Strength (100mg, 250ml, etc.)

132. Quantity per shipment (kgs., litres, units)

133. Packaging (drums, bottles, strips) – MULTIDOSE, PRE-FILLS

134. Shipment Packaging requirements

135. Labeling Requirements – Regulatory ComplianceAmbianceVentures USA

136. DIAGNOSTIC TEST KITSBlood Glucose

137. INFLUENZA

138. Pregnancy

139. HIV ( 1 & 2)

140. Hepatitis

141. Malaria

142. Dengue

143. Chikungunya

144. Syphillis

145. TB

146. Cardiac Markers

147. Dry Chemistry

148. Bio-chemistry

149. Hematology

150. Immunology, Rheumatology

151. ELISAs for Body FluidsIdeal for Rural Clinics, Pharmacies; can be manufactured ‘Private Label’AmbianceVentures USA

152. OUR SPECIALTY: Branded MarketingLeverage low cost contract manufacture at our facilities!NEUTRAL LABEL, PRIVATE LABEL CONTRACT MANUFACTURE:Hospital Supplies, Vaccines, Generics, Cosmetics, Diagnostics, FMCGPhysician Office SuppliesCustom Packaging – For Re-distributionNeutral (‘generic drug’) labelingper Ministry of Health requirementsof numerous Countries in multiple languagesIn Portuguese / English / Spanish / French / Cyrillic / German / ArabicPrivate labeling with your own Brand Name, Company Identity, Compliant with regulations – Pharmacies, HMOs, Export, or forSecondary DistributionAmbianceVentures USA

153. A Division of Ambiance Ventures Distribution Offices in Mumbai (Bombay), India:Fully staffed office (52 FT employees)

154. 5000 sq. feet of Warehouse space

155. Cold Chain refrigerated facility: 1500 sq. feetSales and Logistics Office in Manila, Philippines:We are Authorized Purchasing Agents for the Govt. of PhilippinesAll requirements from India by Philippines Ministry of Health are purchasedthrough us – ‘one-stop-shop’ for vaccines, generics, hospital products from multiple suppliers.All logistics is coordinated by our Manila office.

156. All Philippine Govt. tenders are routed through us.Affiliate Offices in China:Sourcing offices in Guangzhou, Yiwu, Shenzhen, Hong Kong, ShanghaiOTC, Dental Hygiene Contract Manufacturing Plant in DubaiAmbianceVentures USA

157. Our Business Model – The Power of Bulk Buying and Bulk Freighting28 Years of international business with integrity and efficiency

158. One-stop-shop for multiple products resourced from numerous mfrs.

159. We specialize in small orders and shipments - consolidated into container loads

160. Not all mfrs supply all your requirements. We source for you and consolidate smaller shipments for FCL rates

161. Helps your customers to minimize paperwork and transactions with multiple buyers – e.g. multiple letters of credit, multiple bills of lading

162. We take on the ‘headaches’ of logistics and excise /customs at port of origin even for smaller shipments to combine loads into affordable freight rates AmbianceVentures USA

163. Our Business Model – The Power of Bulk Buying and Bulk FreightingOur volumes enable us to buy in bulk – hence better pricing, than if you were to direct buy from the manufacturer!

164. We pass the benefits on to you!

165. We represent manufacturers from India, China, Thailand, Europe, United States

166. All clients we represent are WHO, cGMP compliant, and many are ANVISA, US-FDA or EMEA approved

167. We work with you for Due Diligence including your visits to mfg. facilities in Asia for monitoring regulatory compliance, inspections

168. You can leverage low cost contract manufacturing at our facilitiesAmbianceVentures USA

169. Affiliate of Ambiance Ventures USA We are yourOffice Address in India As our Partner / Client, you may use our Offices and Warehouse facilities in Mumbai (Bombay) as your own:On your WebsiteOn LetterheadsIn Correspondence and ApplicationsDuring visits to India by you or your clients Separate Phone and Fax lines for your company Assign a designated rep to respond on your behalfAmbianceVentures USA

170. BRAZIL - UpdateGovt. Market H1N1: Brazil’s MinisteriodaSaude is buying a total of 83 million doses of vaccine against influenza A virus (H1N1), which will be used in a vaccination campaign planned for the period March to April 2010 – FIRST ROUNDSupply contracts: GSK, Sanofi Pasteur - 33 Million doses from Sanofi at $7.60 /dose via InstitutoButantan for first responders and susceptible populationPAHO to provide 10 Million doses later(??)Potential for at least 5-6 Million more doses if price is right!(Priority groups such as pregnant women, health workers involved in patient care, children from 6 months to 2 years, indigenous people and people with chronic pre-existing conditions (cardiac, pulmonary, renal, metabolic, etc.) Details of strategy will be announced early February).Private Market H1N1: 12-15 Million dosesSeasonal:Public: 17 Million doses; Private: 3 Million dosesAmbianceVentures USA

171. Brazilian Vaccines MarketEstimating a CARG 6.5%/Year: The Market in 2008  $ 330 million (US$ =2.00)AmbianceVentures USA

172. LATIN AMERICAStrong Market Leadership in Brazil, Argentina, Mexico (75% population of Latin America)Market Development:Stage 1: Brazil, Mexico, ArgentinaStage 2: Colombia, Chile, Bolivia, Venezuela, Central AmericaStage 3: Other LatAm countriesAmbianceVentures USA

173. LATIN AMERICATherapeutic Areas / Markets of interest: Vaccines – Complete Portfolio

174. Cardiovascular

175. Anaphylaxis and Emergency Care

176. Plasma-derived Therapeutics

177. AntiVenomsAmbianceVentures USA

178. ASIA, MIDDLE EAST, CIS, AFRICAINDIA: Government Licensed Importer, Distributor with strong network.28 years in Pharma, Biotech Distribution, Imports and ExportsHigh level connectionsASEAN Countries: Government Authorized Sourcing agents in Philippines, ASEAN NationsMarketing / Distribution set - up in:ASEAN (14 countries)

179. Russia, Other CIS countries, Central Eastern Europe

180. Eurasia & PacRim

181. Middle East

182. AfricaAmbianceVentures USA

183. GLOBAL MARKETING, TRADE & BUSINESS STRATEGYWe market in the following countries:North America: United States, Canada, MexicoEuropean Union: United Kingdom, Germany, Italy, Russia, Bulgaria, Hungary, Portugal, Spain, IrelandLatin America / Central America:Argentina, Brazil, Chile, Bolivia, Peru, Panama, Caribbean Is., Guyana, Surinam, ColombiaAsia, West Asia & Pacific: Afghanistan, Bangladesh, Bhutan, Cambodia, China, Indonesia, Iran, Iraq, Jordan, Middle East Nations, Malaysia, Philippines, Sri Lanka, Taiwan, Turkey, VietnamAfrica:Cameroons, Congo, Egypt, Ghana, Kenya, Libya, Mauritius, Morocco, Sudan, South Africa, Uganda, ZambiaCIS Countries:Ukraine, Russia, Kazakhstan, Uzbekistan, Armenia, TajikistanAmbianceVentures USA

184. Contact: Jay NadkarniAmbiance Ventures, USAP.O. Box 622, Swiftwater, Pennsylvania 18370 (USA)Tel: 570/ 460-1804Jay@AmbianceVentures.com; www.AmbianceVentures.comContact: Valerian LoboLOB International, IndiaG-6 Khira Industrial Estates, B.M. Bhargava Rd.Santa Cruz (W), Mumbai 400 054 (INDIA)Tel: 9122- 2661-5006, 9122-2661-6008Val@Lobin.com; www.lobin.comAmbianceVentures USA

�ݺ�ߣ

Global Mktg Presentation 3.0

More Related Content

Global Mktg Presentation 3.0

Editor's Notes