Phalcon Consulting Dr. A. Emmendörffer

Phalcon Consulting is providing coaching, training and auditing services.

Basing on long-term experience in biotech, regenerative medicine, pharmaceutical and medtech companies these services include support in regulatory affairs, quality assurance (FvP, QP), GDP compliance and operations (interim management).

For life science startup companies and / or investors support is provided by assessing business plans, developing RA/QA and reimbursement strategies.

Due to a international network of specialized service providers we are able provide information and support in EU countries and US.

‘- Medical Devices: Technical File, Consultation Dossier, Combination Products
– Product range: orthopedic, cardiovascular (both class III), neurology
– Risk Management (ISO 14971)
– Biocompatibility (ISO 10993 series)
– Medical devices utilizing animal tissues and their derivatives (ISO 22442 series)