New challenges in new times
Today’s biotech and medical device companies are facing new challenges in a post-COVID world, particularly in the regulatory, clinical and commercial areas.
Since the pre-COVID era, the regulatory roadmap has gained significant importance in the product development plan, while commercial needs now play a crucial role in identifying endpoints that were previously overlooked in clinical development plans
Key competencies
The scope of our expertise includes:
- Target Product Profile (TPP) and Clinical Development Plan (CDP) consultations
- Regulatory and clinical roadmap alternatives
- Data collection plan strategy, including animal studies, first-in-men clinical trials, phase 2/3 studies, post-marketing studies, and safety surveillance
- Outsourcing strategy and CRO/CDMO management
- Reassessing the value of the product and presenting it to internal and external key stakeholders, including potential investors.
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We handle our projects in a holistic manner, recognizing the full range of challenges associated with product development and marketing.
