Biotechnology Companies

Establishment of "Medical Affairs / Medical Operation"

Especially for biotechnological start-ups the question arises early in which way the unit "Medical Affairs / Medical Operation" shall be positioned.

In general terms, there are the following functional units:

Medical-Scientific Department
Clinical Research (in particular study management and administration)
Drug Safety / Pharmacovigilance
Regulatory Affairs
Quality Standard Management
Reimbursement / Market Access

Thus, you are facing a fundamental decision at a very early time point after start up:

Which units shall be covered internally, which units can be covered by external service providers, respectively. Within this context, economic considerations must inevitably be taken into account.

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