关于我们

公司概况

成立于2004年,作为医药解决方案的服务公司,基于我们丰富的行业经验和灵活的运作能力,致力于为客户提供全面且独家定制的解决方案,来解决客户在注册法规、产品开发、工程以及市场领域所面临的挑战。

目前,放眼全球,PharmSol集团现拥有8家子公司,遍布欧洲,亚洲以及中东地区。通过在各个地区的本土布局,PharmSol为所有客户提供了“单一窗口”访问的综合解决方案,这确保了所有任务的无缝和及时交付。

我们旨在提供综合全面且量体裁衣的针对性的服务,从而满足客户对于欧盟、美国、澳大利亚、WHO等不同官方法规要求下的产品开发、专利评估、厂房设计、合规指导、法规注册、产品上市以及供应链等领域的需求。

PharmSol不仅开展审计,同时也可以委派专家团队到客户场地管理合规工作,从而帮助客户成功通过不同官方的检查,如美国FDA、欧盟、澳大利亚以及WHO等。PharmSol注重反应速度、交付时间、客户服务以及节约成本等方面并超越客户的期望。

PharmSol可以有效的帮助客户成长并开发高质量的产品,并以长期合作有益于客户的态度来开展工作。

我们以能够对复杂的全球医药商业环境及法规要求的一丝不苟的评估以及认真负责的解读而自豪。

1000+次以上的审计

45+个产品开发
40+个技术转移

25个欧盟/美国/WHO的工
厂认证

50个以上的分析方法开
发/验证

我们灵活的流程和专注的专业知识使我们能够克服任何最具挑战的障碍。

PharmSol不仅开展审计,同时也可以委派专家团队到客户场地管理合规工作,从而帮助客户成功通过不同官方的检查,如美国FDA、欧盟、澳大利亚以及WHO等。PharmSol注重反应速度、交付时间、客户服务以及节约成本等方面并超越客户的期望。

PharmSol可以有效的帮助客户成长并开发高质量的产品,并以长期合作有益于客户的态度来开展工作。

我们的使命

为进入全球医药业务赋能

 我们的愿景

通过为我们客户的业务带来有能力的和综合全面的知识、专业技能和解决方案而不断被重视

里程碑

  • Pharmaceutical Solutions FZCO (迪拜)成立

  • “独家投资开发有专利保护原料药”商业模式诞生

  • “制剂合同开发”和“技术转移”业务启动
  • 根据EC Directive 2004/27/EC,第三方审计业务全面开启

  • PharmSol Europe Limited (马耳他)成立

  • Pharmaceutical Solutions DMCC(迪拜)成立
  • 组建迪拜新办公室

  • 上海办事处成立
  • 开始参加CPHI中国和CPHI欧洲展会

  • PharmSol GmbH(德国)成立

  • PharmSol MPCC LLC (迪拜)成立
  • PharmSol APAC Ltd (香港)成立
  • PharmSol India Pvt. Ltd (印度)成立
  • 从2007年开始至今已有超过500次审计记录

  • PharmSol GmbH (德国)成为BPI和VCI成员
  • PharmSol 印度子公司成功获得ISO 9001:2008资质认证

  • PharmSol中国珠海子公司成立
  • PharmSol印度子公司扩建
  • PharmSol 10名审计官荣获CEIV(IATA)资质认证

  • 同中国客户达成战略性合作伙伴关系

  • PharmSol印度公司通过 ISO 9001:2015认证
  • 已开展超过900次审计

  • PharmSol印度Ahmedabad, Gujarat办事处成立
  • PharmSol(南京)医药子公司成立

管理团队

Sunil Doshi

总经理

总经理

Sunil founded PharmSol in 2004 and led the company as Managing Director. His
C-level substantial expertise in all facets of Pharmaceutical Business, Diversity Management, International Business, Mergers & Acquisitions and Strategic Alliances brought PharmSol to operational level of excellence and growth.

A Chemical Engineer by qualification, with over 36 years of leadership experience in large pharma and established track record of entrepreneurial success within the pharmaceutical industry. Prior to founding PharmSol, he served for 20 years in various MNCs of repute. He has designed and mentored several green field projects for APIs and FDFs, all of which have been USFDA and/or EU certified.

S. Lakshminarasimhan

首席运营官

首席运营官

Lakshmi is the Chief Operating Officer of PharmSol Group, having responsibility for the company’s strategy function and stakeholder relationships including clients’ relations, and corporate responsibility.

He has over 26 years of diversified expertise and operational experience in Regulatory Affairs, QA, IPR, Bulk Drugs, Formulations and Fine Chemical Industries. Prior to his current role, Lakshmi worked in various Indian MNCs and International Companies.

Lakshmi is a Pharmaceutical Technologist with Post Graduate Diploma in Patent Law and an MBA in Operations, International Business. His professional accreditations include APIC Certified Auditor, Associate Member of European QP Association, ECA Certified Computer Validation Manager, formerly certified for Temperature - Controlled Cargo Operations and CEIV Pharma Independent Validator of IATA.

Christian Duchow

总监

总监

Christian has been a Director of PharmSol since inception. He is an entrepreneur with extensive experience in the pharmaceutical & allied fields, has been a guiding brain behind foundation of several businesses in Europe. At PharmSol, he has been supporting the strategy and business development functions.

He is a graduate in logistic operations and has transitioned into pharmaceuticals early in his career. His skills in leadership and expertise in assembling people together, while achieving essential aspirations have led to multiple achievements throughout the years.

Borut Strukelj

高级科学顾问

高级科学顾问

Borut holds a Post Doctorate in molecular biology and has a rich experience of over 35 years into the field of Biosimilar, Nano Technology, Biochemistry and Biotechnology. He was one of the key members of the committee on drafting the EU Guidelines on Biosimilar and was also appointed as an expert in European Pharmacopeia for biological pharmaceuticals as well as at the European Agency for Medicines in London (EMEA). Borut co-authored several patent applications and has written over 180 scientific and professional articles which were published in more than 100 leading scientific journals.

Currently, he is heading the Biotechnology Unit and is a full-time professor at the Faculty of Pharmacy of the University of Ljubljana. He is also a part of Editorial Board of the official journal of Slovenian Pharmaceutical Society and International Journal of Medicinal Mushrooms. As a Senior Scientific Adviser of PharmSol, he directs the PharmSol Team that focuses on the development, compliance, and regulatory aspects of biopharmaceutical projects.

Rajeev Patil

总监

总监

Rajeev is a technocrat with over 39 years of experience in the Pharmaceutical Industry of which a long stint of 31 years as Head of Global Regulatory Affairs at Lupin. He set a record for getting more than 170 approved ANDAs, guiding numerous successful US FDA inspections, more than 100 Market Authorizations in EU and Australia, prequalification of more than 15 products by WHO, playing significant role in all major regulatory audits of Lupin since 1989.

Currently as one of the Directors of PharmSol Group, he is involved in providing business solutions in Pharmaceuticals in the arena of Compliance, Regulatory and Project Management.

A postgraduate in Technology of Pharmaceuticals and having extensive experience in the Regulatory Affairs of Drug Products and APIs, Compliance Audits and Product Development (drug product as well as API) for US Markets.

Andrej Gasperlin

高级商务顾问

高级商务顾问

Andrej is a US based Pharmacist and Entrepreneur with a range of global experience. He brings to PharmSol a rich global experience of over 25 years within the areas of product development, cross licensing, technology transfers and strategic alliances negotiations and other related operations within the pharmaceutical industry.

He holds an Executive MBA degree in Pharmaceutical Marketing and has been supporting several international companies in the business of generics in the USA. He is also the Founder and President of AB Pharmaceuticals Inc.

He is an active member of the American Pharmaceutical Association as well as a member of the pharmaceutical technical committee in the Slovenian Pharmaceutical Association. He has been a member of the board of directors of the Generic Pharmaceutical Industry Association (GPIA) and member of several other committees of the Generic Pharmaceutical Association (GPhA).

Smita Kavishwar

合规&法规副总

合规&法规副总

Smita has over 24 years of experience in the Bulk Drugs and Specialty Chemical Industries in Quality Functions, Regulatory Affairs, IPR and Research & Development. She is currently the Vice President – Compliance and Regulatory Affairs of PharmSol Group, her main focuses are leading the Regulatory Affairs Department, managing registration and compliance of a large portfolio of products besides supporting GMP compliance and certification.

She holds a Ph. D. Tech (Pharmaceutical Chemistry) and Masters of Pharmaceutical Sciences. Her professional accreditations include Certification in IPR GNA Patent Gurukul, Certificate for ECA - Lab Data Integrity, APIC Certified, formerly certified for Temperature - Controlled Cargo Operations and CEIV Pharma Independent Validator of IATA.

Ravikanth Mandapati

质量管理副总

质量管理副总

Ravikanth is the Vice President – Quality Affairs of PharmSol Group. In this role, he heads the QA/QC functions, leading the execution team for several technology projects for Formulations and acting as the Chief Inspector of pre-dispatch inspections for API & Formulations.

With over 25 years of experience in the areas of Quality Control and Quality Assurance for Bulk Drugs & Formulations, Ravi has also worked across many areas of PharmSol providing support in the 3rd Party GMP Audits and EUGMP Certification projects of PharmSol and acted as Independent Validator towards CEIV Pharma of IATA.

He holds a Masters’ Degree in Chemistry and obtained a Diploma in Chemical Processing & Instrumentation Control and Certificates for ECA - Lab Data Integrity, APIC Auditor and CEIV Pharma Independent Validator of IATA.

Abhay Asthana

项目总经理

项目总经理

Abhay is the General Manager, Projects of PharmSol Group. He is leading the Product and Technology Development functions. He holds a Ph. D. in Pharmaceutical and has been into industry and academics for over 17 years. His professional expertise includes design and development of platform technology, formulation research, process efficiency enhancements, QBD guidelines, scientific community publications and IPR.

Medarametla Rambabu

技术服务总经理

技术服务总经理

Rambabu is the General Manager - Technical Services, looking after the manufacturing, tech transfer and outsourcing functions. He is a M. Pharm in Pharmaceutics and has over 20 years of core experience in pharma production, project management, facility design and upgrade among others.

Felix Huang

中国商务开发总监

中国商务开发总监

Felix, as Director – China Business Development, leads the business development and growth management functions for PharmSol in China. Prior to joining PharmSol, he has been into diverse roles including business development of CRO, marketing of food & nutraceutical ingredients, among others. He brings with him a strong network of Chinese pharma entrepreneurs.

He holds a degree in Information Technology from GD Industry Technical College, China.

Nancy Yao

中国区技术运营总监

中国区技术运营总监

Nancy has been one of early members of Team PharmSol based out of China and has since grown to become the Director of Technical Operations. She leads a team of compliance and technical experts of PharmSol in China. She has professional expertise in conducting GMP/QP audits, coordinating EU GMP Certifications and project management. Graduated from Shenyang Pharmaceutical University and has about 11+ years of experience in various technical regimes of pharmaceutical industry. She is qualified as an ASQ certified quality Auditor/APIC certified Auditor and Member of European Compliance Academy. As a certified lead auditor, she has successfully performed 200+ audits for various pharmaceutical companies manufacturing OSD, Sterile Dosage formulations and sterile and non-sterile API.

Shawn Xiao

中国商务开发总监

中国商务开发总监

Shawn has been with PharmSol for 8+ years as part of the Business Development and Commercial Operations in China. As Director – China Business Development, he played a key role in building the local set up of PharmSol in China.

With over 15 years of pharmaceutical industry experience with comprehensive expertise in sourcing, import and export of API and intermediates from China, he notably leads the PharmSol Team in dealing with overseas transactions and partnerships on supply chain.

Shawn obtained a Master’s Degree in Business Administration from Macau University.

合作机遇

  • 我们渴望同和我们一样的价值观、职业道德和工作质量的客户、合作伙伴及顾问合作。我们高度重视认可伙伴关系及合作,作为我们商业战略的重要组成部分。
  • 您愿意加入合作成为其中一员吗?
  • 我们将非常愿意为您提供帮助。欢迎同我们的管理团队联系。
联系方式

我们的机构

PharmSol GmbH

Bad Oldesloe, Germany

PharmSol Europe Limited

Mosta, Malta

Pharmaceutical Solutions FZCO

Jebel Ali, Dubai, United Arab Emirates

Pharmaceutical Solutions DMCC

Jumeirah Lakes Towers, Dubai, United Arab Emirates

PharmSol India Pvt. Ltd.

Hyderabad, India

PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd

Nanjing City, Jiangsu Province, PR China

PharmSol APAC Limited

Hong Kong, China