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Hecker & Associates, LLC

Product Development Experience
Regulatory Strategy
US Agent
Seminars and Events

307 North Garfield St.
Arlington, VA 22201-1261



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Regulatory Strategy,
FDA Meetings and Submissions Project Management

Picture of Sandra J Hecker

Because she started her career as a medical writer, Sandy focuses on helping companies write concise, efficient FDA meeting requests and briefing documents, clinical protocols, investigator brochures, and other key clinical trial application (CTA) submission documents to comply with current regulations, and relevant guidance for specific indications, types of products (e.g., gene therapies), and International Conference on Harmonisation (ICH) topics. She also specializes in writing INDs that can be easily transformed into (or from) CTAs in other world regions. Her long-standing interest in writing and clear language ensures the non-native English writing of her foreign clients is easily understood by FDA, resulting in fewer FDA questions and a faster path to the market.

Sandy helps her clients meet orphan drug, clinical trial, drug safety /pharmacovigilance, and marketing application requirements to ensure multi-region projects are handled in the most efficient way. She and her colleagues ensure an initial clinical trial application (e.g., an IND for FDA) is complete and concise, facilitating its prompt, successful FDA review resulting in an FDA “allowed to proceed” decision. She maintains the IND/CTA by filing protocol amendments, annual reports/DSURs, time-sensitive safety information for clinical trial patients, FDA meeting requests, and ensures all project regulatory requirements are met. Sandy frequently interacts with FDA staff to ensure projects stay on track.

Because Sandy lives and works near FDA, she frequently participates in FDA “information for the industry” and FDA Advisory Committee meetings that relate to her clients’ projects.