"BUSINESS DEVELOPMENT IN GMP FINE CHEMICALS"
Paolo Romagnoli
The reference book for all managers and investors directly or indirectly involved in the manufacturing of Fine Chemicals for the pharmaceutical Industry requiring compliance with Good Manufacturing Practices. This book is mainly addressed to top and middle managers involved in Business Development activities in GMP – Fine Chemicals, but may be found of interest also by investors, financial institutions, suppliers, customers, commercial organizations, authorities and other parties willing to understand the mechanisms and characteristics of a complex high-tech Industry with very attractive future perspectives.
"I was anxious to put on paper all the thoughts, notes and
experiences collected in my career".
"I strongly believe there are no other industries with such a variety of problems, where each of the thousand products and technologies involved has its own story, where each company is different from the other, where regulations are so complex and changes so continuous".
Fine chemicals have always been a large component of the chemical world, with sales of many tens of billion US dollars. The largest share of fine chemicals consumption is made up by those products used directly or indirectly by pharmaceutical industries as Active Ingredients of
medicinal products having therapeutic or prophylactic properties.
In order to assure a suitable quality of the medicinal products for human or animal use, health authorities of most countries require that all their Active Ingredients are to be manufactured and controlled in accordance with specific procedures called Good Manufacturing Practices, or GMP.
GMP requirements have been recently harmonized at international level and have been published in official guidelines. The US edition of these guidelines has been enclosed in this book for easy reference. GMP compliance became a factor of huge strategic, industrial and economic impact; the manufacturing activities have been classified no more as a simple segment of the larger fine chemical sector, but as a separate and well defined Industry. This Industry has its own players, specific business environment and internal segments. It is here called GMP – Fine Chemicals, abbreviated as GMP – FC. The aim of this book is to supply all parties involved "Business development in GMP Fine Chemicals" with a tool to analyze the Industry and its perspectives, to make an internal assessment of what is available, to define the most appropriate growth plans and to verify the suitability and affordability of potential new
opportunities.
The concepts described in this book come from the 29 years experience of the author as manager and consultant in the GMP – Fine Chemical Industry, and from a continuous analysis of the best practices of leading organizations in the same area.
The book does not want to give fixed rules which can be appropriate for a company and damaging for others, but would like to rise more questions and to push the readers to find their own answers after an adequate thinking. If the final result will be a significant improvement of the quality of decisions made by an organization, the purpose of the book might then be considered fundamentally achieved.
CONTENTS
FROM THE AUTHOR
PREFACE
INTRODUCTION
1. GMP – FINE CHEMICALS: INDUSTRY DEFINITION
2. CORPORATE STRATEGY AND BUSINESS DEVELOPMENT
3. MACRO-ENVIRONMENT AND MEGA-TRENDS
4. MARKET STRUCTURE AND PERSPECTIVES
5. INDUSTRY STRUCTURE: THE OFFER
6. TECHNOLOGY AND MANUFACTURING
7. REGULATORY AND LEGAL ENVIRONMENT
8. COMPANY REPORTS AND REFERENCE DOCUMENTS
9. COMPANY PERFORMANCES
10. ORGANIZATION
11. COMPETITIVE FACTORS
12. INTERNAL ASSESSMENT AND COMPETITIVE POSITION
13. OPPORTUNITIES AND PROJECTS ASSESSMENT
14. DEFINITION OF A DEVELOPMENT PLAN
15. IMPLEMENTATION OF A DEVELOPMENT PLAN
ABBREVIATIONS
REFERENCES
Q7A GOOD MANUFACTURING PRACTICE GUIDANCE FOR ACTIVE
PHARMACEUTICAL INGREDIENTS
ANALYTICAL INDEX
To request copy of the book e-mail info@romagnoliconsulting.com
