Spot-On Pharma Consulting

Professional services Manufacturing & process dev, Product development, Regulatory / Quality Consultancy Copenhagen, Denmark Founded 2023 1–10 employees

Contract & specialist services Cell therapy (sCTMP) Combined ATMPs Gene therapy (GTMP)

We provide support within areas shown below:
1. Preparation of strategy for CMC development and GMP manufacturing
2. Project management within CMC development and GMP manufacturing
3. Product and process development for drugs/biologics and combination products
4. Specifications and stability programs
5. Upscaling and tech transfer
6. Qualification and process validation
7. Outsourcing to and oversight of CDMOs
8. Preparation of regulatory CMC documents for IND/CTA and market approval

Contact

erik@spotonpharmaconsulting.com

+45 42596667

spotonpharmaconsulting.com

Fruebjergvej 3, 2100 Copenhagen, Denmark