Many businesses and entrepreneurs encounter similar issues in their commercialization journeys. The NYS STLC has produced guidebooks that provide additional information on some of these issues.

The Startup Guidebook

This guidebook was compiled by the New York State Science & Technology Law Center to assist individuals working together to grow a business based on new technology. Founders, especially in the technology industry, are famously focused on the research and development of their product. However, several business issues can cause real trouble in the future if not addressed early on.

This book has checklists to devise a Memorandum of Understanding (MOU) providing guidance on critical, difficult, and divisive issues that must be discussed at the beginning of a business venture. A startup checklist covers the typical necessary actions of new companies, and a Founders Agreement template and guide are included.

The FDA Guidebook

This guidebook was compiled by the New York State Science & Technology Law Center to assist individuals working to commercialize a new medical device, drug, or substance for use in food. While inventors and researchers traditionally have a strong command of the science and engineering required to develop a new product, a lack of familiarity with the Food and Drug Administration’s approval and oversight procedures often leaves companies underequipped to pursue the financially onerous time commitment necessary to bring a product to market.

This guidebook addresses some of the common questions and procedures that companies with drugs, medical devices, and substances for use in food will encounter during the early regulatory process. Topics include the difference between a drug and a device, how to determine the classification of a medical device and submit a device for approval, an overview of the investigational new drug process, an explanation of the over-the-counter drug monograph system, and GRAS policy.

Guidebook for Establishing an Internet Presence

Internet and wireless communication systems have revolutionized business opportunities. Due to its convenience and versatility, Internet commerce generates billions of dollars each quarter. The Internet provides an easy way to present product information and facilitate communication with clients. However, with these advances come new legal, regulatory, and marketing challenges.

This Guidebook was compiled by the New York State Science & Technology Law Center with the aim of providing entrepreneurs information about establishing an Internet-based business or online presence.