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, …).

Below are the main missions of our R&D team:

 

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

Expertise

Dietary supplement
OTC
Generic medicines
Niche products
MAA files
Complex galenic forms

Any questions?

Want more information about our services, our expertise or how to work with us?

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