What ReMedys does – Who we are...

Founders & Management Team

The ReMedys’ team consists of pharmaceutical industry professionals. The team monitors program deliverables, timelines and oversees the general development of projects and the foundation.

Dr. Bridgitte Happ

Regulatory Affairs

Dr. Happ holds a PhD and brings to ReMedys 19 years of experience in regulatory affairs.
She has delivered successful applications for new biotech products, devices, and lifecycle management worldwide, including EU (via centralised procedure, mutual recognition and national procedures), Japan and USA.

She successfully negotiated with EMA and EU national agencies and participated in FDA, TGA and Health Canada meetings. Dr. Happ has a broad therapeutic development expertise metabolic endocrinology, reproductive health, dermatology, oncology and rheumatology. She is a recognized training expert on clinical development with focus on regulatory affairs topics and has been an invited speaker to several international conferences & training courses on Orphan Drugs. Dr. Happ is ReMedys key consultant on al regulatory matters.

The  Foundation also has networks with professionals in the fields of animal safety/toxicology, regulatory affairs, drug metabolism/ pharmacokinetics, human pharmacology, manufacturing, clinical trial design, statistics, clinical research, clinical trial management, safety, business development, and project management.  Making these experts available as needed to projects ensures state-of-the-art development and increases the likelihood of success.