Haffner Associates, LLC

Biotechnology ResearchUnited States2-10 Employees

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.

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