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&
An Alliance of Capabilities…
…Advantage Vietnam Pharma
PharmSol Group of Companies
Smart Products, Bespoke Solutions
Global
Presence
Products
Licensing & Supply
Contract
Development &
Manufacturing
Co-developments Tech Transfers
Product List available on request….
Solutions
Track Record
Products Solutions
Leadership
Sunil Doshi
Founder & Managing Director
36 Years of Global Techno-commercial
Expertise in Pharma Industry
S. Lakshminarasimhan
Chief Operating Officer
25 Years of Pharma Technology,
Compliance & Regulatory
“Leading a global team of 80 committed professionals.”
Christian Duchow
Director – EU Business
30 years in European
Pharma Business
Borut Strukelj
Senior Scientific Adviser
35 years of expertise in Biotech,
Biosimilars & Regulatory
Andrej Gasperlin
Senior Business Associate - US
35 years in US Pharma Business
Arun Sehgal
Director – Strategic Business
40 years of expertise in Pharma
Business and Management
Strategy Team
SMEs
Felix Huang
Director – China, BD
10 Years in China Pharma Business
Nancy Yao
Director – China, Technical
Operations
11 Years in China Pharma with Compliance
Manish Rajeshirke
Vice President – Business
Development
21 Years in International Pharma Business
Rajeev Patil
Director –Regulatory Affairs
40 years of USFDA Compliance &
Regulatory expertise
Ashish Dasgupta
Senior Scientific Adviser
40 years of expertise in
Clinical, Quality & Regulatory
Ganesh Sangaiah
Director – NDDS
26 years of expertise in NDDS
Accreditations
Some of Our Esteemed Clients…
Superior Quality Higher Affordability Reliable
Service
40+
170+
35+
25+
50+
Global Presence
Products & Services
Track Record
50+
Manufacturing Partners
(FDF)
200+
Manufacturing Partners
(API & Intermediates)
15+
Manufacturing Partners
(KSM)
10+
Impurity Manufacturing
Partners (WS & RS)
5+
Regulatory Support Partners
(BE Studies)
10+
Foreign Partners for Exclusive
Raw Material Supplies
Leadership
Leadership
Clientele
Synergy
PharmSol Chempro
Experience 50(+) years 80+ years
Focus Areas Finished Pharmaceuticals, Biopharma APIs / KSMs / Excipients
Capabilities
IPR, Technology, R&D, Manufacturing, Global
Compliances, Regulatory, Marketing
Contract development, Manufacturing,
Technology, Supply Chain, Marketing
Core Competence Enabling EU, AU & US Market Access
Enabling long-term sustainability by
Integration
Team
75+ in-house technocrats. Renowned
Industry Experts in the field of Pharma,
Biosimilars, Clinical
Strong local and international networks of
industry experts
Empowering Vietnam
Pharma
Empowering the Vietnam pharma industry to achieve a sustained profitable growth
by:
• Enabling Local Manufacturing
• International Compliance (EU, US, AU, CA)
• Providing Global Market Access
• Competitiveness over Lifecycle
• Products in Group 1
Bringing Best of the Pharma World to Vietnam…
&
Introducing Vietnam Pharma to the World…
Approach
Efficient &
Cost
Competitive
Technologies
Reliable
Supply Chain
International
Compliance
Global Market
Access
Business Model…
Biopharmaceuticals
 Access to Biopharmaceuticals at affordable cost
 Enabling Local Manufacturing
 Creating Global Footprint
Key Objectives
 In-licensing & Registrations
 Technology Transfer from Corporates, Universities, Government
Institutions
 Establishing Domestic Biopharma – Development & Manufacturing
 IPR – Non-Infringement & Patenting
 Instituting International Quality and GMP Standards
 Foreign Regulatory Approvals
 Out-licensing & Exports
Approaches
Strengths
 Renowned Experts
 In-house Team
 Access to CROs
 Approach to International Regulators
 Network with leading marketers
Prof. Borut Štrukelj, M Pharm, PhD, Post Doc – Molecular Biology
• A globally renowned expert in biopharmaceuticals, gene therapy and vaccines with 35+ years of experience
• An eminent expert in the field of A decade long experience of working as an expert with EMA
• Architect of EU Biosimilar Guideline, governing the business of Biosimilars in EU
• Adviser on the European Pharmacopeia Convention
• Active engagement with several leading MNCs – Novartis, Sanofi, Pfizer, Amgen, Janssen, Roche; providing
leadership and guidance in Development, Compliance and Regulatory aspects of Biomedicines
• Currently heading the Biotechnology Unit at University of Ljubljana
• Several patent, 180+ scientific articles in 100+ journals
• Member of FEBS, SFD, IUBMB, IUPMB, SDRF
• Recipient of Zois Prize (2015), the Minarik award (2011), the Fulbright Award (2010), the Zois award (2007),
the Boris Kidrič Fund Prize (1991)
• Visiting professor at the Duquesne University, Pittsburgh, USA.
Expert Profile
Thank You!

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PharmSol_Chempro_Vietnam Synergies

  • 1. & An Alliance of Capabilities… …Advantage Vietnam Pharma PharmSol Group of Companies
  • 3.
  • 5. Products Licensing & Supply Contract Development & Manufacturing Co-developments Tech Transfers Product List available on request….
  • 8. Leadership Sunil Doshi Founder & Managing Director 36 Years of Global Techno-commercial Expertise in Pharma Industry S. Lakshminarasimhan Chief Operating Officer 25 Years of Pharma Technology, Compliance & Regulatory “Leading a global team of 80 committed professionals.”
  • 9. Christian Duchow Director – EU Business 30 years in European Pharma Business Borut Strukelj Senior Scientific Adviser 35 years of expertise in Biotech, Biosimilars & Regulatory Andrej Gasperlin Senior Business Associate - US 35 years in US Pharma Business Arun Sehgal Director – Strategic Business 40 years of expertise in Pharma Business and Management Strategy Team
  • 10. SMEs Felix Huang Director – China, BD 10 Years in China Pharma Business Nancy Yao Director – China, Technical Operations 11 Years in China Pharma with Compliance Manish Rajeshirke Vice President – Business Development 21 Years in International Pharma Business Rajeev Patil Director –Regulatory Affairs 40 years of USFDA Compliance & Regulatory expertise Ashish Dasgupta Senior Scientific Adviser 40 years of expertise in Clinical, Quality & Regulatory Ganesh Sangaiah Director – NDDS 26 years of expertise in NDDS
  • 12. Some of Our Esteemed Clients…
  • 13. Superior Quality Higher Affordability Reliable Service
  • 17. Track Record 50+ Manufacturing Partners (FDF) 200+ Manufacturing Partners (API & Intermediates) 15+ Manufacturing Partners (KSM) 10+ Impurity Manufacturing Partners (WS & RS) 5+ Regulatory Support Partners (BE Studies) 10+ Foreign Partners for Exclusive Raw Material Supplies
  • 22. PharmSol Chempro Experience 50(+) years 80+ years Focus Areas Finished Pharmaceuticals, Biopharma APIs / KSMs / Excipients Capabilities IPR, Technology, R&D, Manufacturing, Global Compliances, Regulatory, Marketing Contract development, Manufacturing, Technology, Supply Chain, Marketing Core Competence Enabling EU, AU & US Market Access Enabling long-term sustainability by Integration Team 75+ in-house technocrats. Renowned Industry Experts in the field of Pharma, Biosimilars, Clinical Strong local and international networks of industry experts
  • 23. Empowering Vietnam Pharma Empowering the Vietnam pharma industry to achieve a sustained profitable growth by: • Enabling Local Manufacturing • International Compliance (EU, US, AU, CA) • Providing Global Market Access • Competitiveness over Lifecycle • Products in Group 1 Bringing Best of the Pharma World to Vietnam… & Introducing Vietnam Pharma to the World…
  • 27.  Access to Biopharmaceuticals at affordable cost  Enabling Local Manufacturing  Creating Global Footprint Key Objectives
  • 28.  In-licensing & Registrations  Technology Transfer from Corporates, Universities, Government Institutions  Establishing Domestic Biopharma – Development & Manufacturing  IPR – Non-Infringement & Patenting  Instituting International Quality and GMP Standards  Foreign Regulatory Approvals  Out-licensing & Exports Approaches
  • 29. Strengths  Renowned Experts  In-house Team  Access to CROs  Approach to International Regulators  Network with leading marketers
  • 30. Prof. Borut Štrukelj, M Pharm, PhD, Post Doc – Molecular Biology • A globally renowned expert in biopharmaceuticals, gene therapy and vaccines with 35+ years of experience • An eminent expert in the field of A decade long experience of working as an expert with EMA • Architect of EU Biosimilar Guideline, governing the business of Biosimilars in EU • Adviser on the European Pharmacopeia Convention • Active engagement with several leading MNCs – Novartis, Sanofi, Pfizer, Amgen, Janssen, Roche; providing leadership and guidance in Development, Compliance and Regulatory aspects of Biomedicines • Currently heading the Biotechnology Unit at University of Ljubljana • Several patent, 180+ scientific articles in 100+ journals • Member of FEBS, SFD, IUBMB, IUPMB, SDRF • Recipient of Zois Prize (2015), the Minarik award (2011), the Fulbright Award (2010), the Zois award (2007), the Boris Kidrič Fund Prize (1991) • Visiting professor at the Duquesne University, Pittsburgh, USA. Expert Profile