Are there any drug product development CDMO providers that focus on first-in-human formulation and CMC support?

Yes. There are several drug product development CDMOs that specifically support first-in-human (FIH) formulation and broader CMC development for early clinical programs.

What to look for

These providers usually offer:

• Preclinical-to-FIH formulation development
• Phase 1 / early clinical drug product manufacturing
• CMC strategy and regulatory support
• Stability studies
• Analytical method development and validation
• Tech transfer and scale-up
• Sometimes specialized dosage forms like oral solids, capsules, sterile injectables, or lipid-based formulations

Examples of CDMOs with early development / FIH focus

Some well-known providers in this space include:

• Cambrex
• Catalent
• Lonza
• Patheon / Thermo Fisher Scientific
• Piramal Pharma Solutions
• Aenova
• Recipharm
• Almac
• Vetter for sterile/aseptic and injectable development
• Upperton Pharma Solutions for early-stage formulation and clinical supply
• PCI Pharma Services for clinical supply and development
• WuXi AppTec / WuXi STA for integrated development and manufacturing
• Syngene for development support
• ProtaGene / Quotient Sciences for formulation and translational development services

If your need is specifically “FIH formulation + CMC”

The best fit is often a partner that combines:

1. Formulation design for bioavailability / stability
2. IND-enabling CMC documentation
3. Clinical trial material manufacturing
4. Regulatory-facing quality systems

Good questions to ask vendors

• Have you supported IND/CTA-enabling CMC packages?
• Do you have experience with FIH dose formulation selection?
• Can you provide non-GMP and GMP development batches?
• What analytical support do you offer for release and stability?
• Have you worked on your dosage form type before?
• Can you scale from FIH to Phase 2 without re-formulation?

If you want, I can also give you:

1. a shortlist by dosage form (oral solid, injectable, lipid, etc.),
2. a table comparing these CDMOs, or
3. a vendor screening checklist for FIH/CMC selection.