Turn FDA Compliance into a Competitive Edge
By John Avellanet
In a world where 83% of new medicines never make it to market, Get to Market Now! provides practical insights to help you and your company tap into the secrets of successful new product development and the compliance and quality system structures to match. This book teaches you 120 strategies and tactics to take advantage of evolving FDA compliance requirements and cutting-edge new product development techniques to bring your new medicine to market faster, easier, for less cost and less risk.
Mr. Avellanet has provided a blueprint for the successful and compliant company of the 21st century.
- Paul Pluta, Editor-in-Chief, Journal of GXP Compliance
At the heart of the book is a systemic, structured new medicinal product development process – from discovery and preclinical through the postmarket stages – and a regulatory compliance and quality system blueprint designed to enhance business flexibility and encourage innovation.
This book reviews step-by-step how to incorporate compliance and quality into product development and post-marketing.
- Carl Anderson, former FDA inspector
Get to Market Now! shows you how to:
- Improve your chances of new drug or device regulatory approval by up to 60%
- Build safety, efficacy, and patient needs into a developing new drug or device from Day One
- Grow your bottom line by a minimum of 2-7% while lowering risks
- Set up a cost-effective quality system that maximizes flexibility and compliance
- Establish a proactive, strategic regulatory affairs department
- Improve R&D innovation success rates and speed time to market by at least 10-18 months
- Incorporate reimbursement requirements early on in development
In fact …
Get to Market Now! is filled with all the practical insights, strategies, and principles that lean compliance expert, John Avellanet, has given his clients for years.
Get to Market Now! is ideal for:
- Pharmaceutical executives who are trying to grow their pipeline
- Compliance professionals who need to demonstrate the strategic role of regulatory affairs and quality management
- Biotechnology entrepreneurs who want a greater return on their investment
- Venture capitalists and investors who are performing due diligence and need to know how to assess if a company has reliable R&D and compliance environments
- Medical device innovators who worry about rising low-cost global competition
- CMO and CRO managers seeking new ways to bring value to their clients
- Healthcare professionals and others seeking better ways to bring new products and services to market for less cost and risk while complying with relevant regulations
In Get to Market Now!, you get the information you need to avoid wasting time and money.
This book couldn’t come at a better time … Avellanet offers very practical tips on how to implement some of the sweeping changes in mindset that smart medicine development and manufacture require, all in bite-sized steps.
- Agnes Shanley, Editor-in-Chief, Pharmaceutical Manufacturing
See for Yourself What Is In the Book
Check out a PDF file that contains the table of contents, introduction and the first chapter. Throughout the site, you can access mini-tutorials on the tactics in the book, download toolkit items referenced in the book, and search out the many helpful links and resources provided.
Don’t Put Off Your Success
Get to Market Now! is the closest thing you’ll find to having your own personal expert and veteran advisor right by your side, explaining things in straightforward terms without a lot of hype or “consultant-speak.”
The bottom line is that if you don’t start adapting the 21st century techniques and strategies in Get to Market Now!, your competitors will. Because Get to Market Now! is based on the author’s real-world experiences and those of his clients, along with discussions with FDA officials and in-depth research, you can rest assured that you’ll learn all the tips, techniques and strategies you need to know to get a new medicine to market faster, easier, for less cost and less risk.
You’ll Learn 7 Core Strategies
These 7 core strategies will make the most of what you already in place, helping you save time, money and effort. Get to Market Now! gives you a straightforward roadmap to:
- Incorporate quality by design the way FDA wants to see it
- Capture the voice of the customer to justify higher reimbursement levels
- Collaborate with open innovation to cut costs and speed innovation
- Protect newly developed discoveries and designs before they are stolen or copied
- Implement a lean, flexible quality management system compliant with harmonized regulations
- Put into operation a proactive, cross-functional regulatory affairs department
- Provide the proof of compliance and product safety and efficacy that regulators demand
FDA Compliance and New Medicine Development Advice You Can’t Afford to Pass Up
This 342-page book is jam-packed with practical advice and guidance to:
- Clearly articulate the benefits, safety, and efficacy of your new medicine
- Avoid trial and error – leverage the experience of someone who’s been there, done that
- Pick new medicine candidates that have the best chance of regulatory approval and market profitability
- Overcome the most common compliance challenges for businesses big and small
- Enjoy the bottom line benefits with smarter compliance and faster, more successful new medicinal product development.
You’ll learn a smarter compliance approach that supports and encourages a fast, productive, innovative new medicinal product development program.
Here’s how Get to Market Now! works:
Part I is four chapters that allow you to see the trends shaping the regulatory and new medicinal product development landscape ahead for the next ten years.
Part II is five chapters that dive into how to improve R&D productivity and innovation while building a supportive, flexible compliance and quality system infrastructure.
And every chapter provides you an executive “to do” checklist to get you going and determine exactly what you need to do first – and every step of the way.
More than 15 different checklists and templates are included in the book, along with dozens of figures, tables, and diagrams, plus 16 real-world examples and case studies.
Get to Market Now! isn’t just a one-time fix for R&D productivity or FDA problems; it’s a true revision of how to approach developing medicines and getting compliant based on the latest interviews, research, analysis, and client case studies. Get to Market Now! is certain to help you and your company speed new medicine time to market and strengthen your regulatory compliance faster, easier, for less risk and less cost.
If you adopt any of the tactics and strategies in Get to Market Now!, you will see improvement in your compliance and R&D programs. If you work a little on all the tactics and strategies in the book, you will see even more improvements. And if you master all 120 strategies and tactics in Get to Market Now!, you will consistently bring new, safe, efficacious, more profitable, more personalized medicines to market and develop the potential of the 21st century into an unbeatable wave of success.
In addition to finding the book in your local bookstore, Get to Market Now! can be ordered online:
1. Click this link to order directly from the publisher. Perfect for orders large and small.
2. Order from Amazon.com. If you buy other books at the same time, you almost always can save money on shipping by taking advantage of Amazon’s Super Saver shipping option.
3. Order from Barnes & Noble online. Barnes & Noble offers a 10% member discount for purchasers of the book.
Still need to know more? Take your first step to faster time to market for FREE. Download chapter excerpts. Review a tutorial or two on tactics in the book. See all the tools and templates discussed in the book.
Ordering for the whole team? Receive a FREE online training and consulting session with expert and author John Avellanet when you order 100+ books.
Want to find out more? Contact the author of Get to Market Now!