Haffner Associates, LLC, was founded in 2009 as a company dedicated to facilitating the development of therapies for the diagnosis, treatment and prevention of rare and devastating diseases.
As a company Haffner Associates specializes in working with -
Biotechnology and pharmaceutical companies of all sizes and stages to:
• create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, evaluation of clinical study design, and trouble-shooting regulatory and development issues,
• author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations,
• develop materials for meetings with the FDA and EMA and assist with meeting preparations,
• facilitate connections with patient advocacy groups and key opinion leaders, and
• interpret policies and communications from regulatory agencies around the world.
Patients and patient advocacy groups to:
• develop and implement policy initiatives,
• identify the right pharmaceutical company to “adopt†a product, and
• navigate the biotech and regulatory communities.
Visit www.MHaffner.com for more information on our company and our team.