Research & Development
Research & Development
Our experienced R&D team handles all development steps from early stage formulation to manufacturing process validation. Our field of application is wide: generics, prescription brands, OTC, food supplements, of any kind of administration forms.
We are duly aware of development dynamics and thus are committed to timelines adherence.
SUBSTIPHARM’s R&D department collaborates with partners and scientific experts all around the world (EU universities, international CDMOs and CROs, …).
Our R&D team's missions
Active Principle Ingredient (API) and Excipients
- Selection and Qualification of suppliers in close collaboration with QA team
- Dual sourcing
- Patent landscape assessment
Formulation and Analytical development
- Selection and Qualification of suppliers in close collaboration with QA team
- Dual sourcing
- Patent landscape assessment
Clinical Trials
- Selection and Qualification of suppliers in close collaboration with QA team
- Dual sourcing
- Patent landscape assessment
Registration (worldwide)
- Selection and Qualification of suppliers in close collaboration with QA team
- Dual sourcing
- Patent landscape assessment
Manufacturing
- Selection and Qualification of suppliers in close collaboration with QA team
- Dual sourcing
- Patent landscape assessment
Regulatory Affairs
Our Regulatory Affairs Team provides our Partners with a full and comprehensive regulatory support, during all phases of the product life-cycle. Their great demand level in dossiers redaction and their expertise in Regulatory strategy design allow us to achieve quickly and successfully any registration procedure we start.
Their tasks comprise:
- Pre-submission activities
- Marketing Authorization Applications through CP/DCP/MRP/NP
- Post-Marketing Authorization Maintenance
- FDA Filing
