R&D

R&D Generics

At AXONE® we have the strategic commitment to be a global partner for the R&D of generic drugs. Many generic international companies already trust us in helping them build and enlarge their portfolio.
In our GMP/GLP facilities, and thanks to our highly professional R&D team, AXONE® offer a fully integrated service managed by our dedicated project leaders, from the selection of API’s, pre-formulation and pilot formulation services, development of analytical methods and validations, stabilities according ICH-guidelines, as well as clinical and bioequivalence studies, until the compilation of the registration dossier and regulatory affairs support.

All these added value R&D services we offer to our partners are completed with the production, manufacturing and licensing-out of our top quality generic products.

Formulation development 

In AXONE® we know that a reliable formulation not only ensures your drug will perform clinically but assures manufacturability and optimal stability. Formulation development is the very beginning of what we have to offer you; a tailor-made pharmaceutical development service.
Our offer of formulation services includes:

  • Pre-formulation
  • Formulation of all oral solid dosage forms
  • Formulation of Transdermal Patches & ODF
  • Formulation of Oral Liquids and Semi-solids (topic & Suppositories)
  • Formulation in soft gelatin capsules
  • Formulation in Liquid Capsules
  • Formulations in drinkable Ampoules
  • Validations, technology transfer and scale-up
  • Manufacturing of pilot and bio batches
  • Production of stability testing batches

Our formulation development are complemented and supported by analytical development services performed in our laboratories.

Analytical development

With state-of-the art analytical equipment suited to fit our clients’ different needs and ensuring smooth technology transfers, we provide analytical support for a wide variety of pharmaceutical development services in compliance with GMP requirements and ICH guidelines.

 

 AXONE can provide you with the following analytical development services:

  • Quality Control release testing
  • Method development
  • Method validation
  • Stability studies
  • Stabilities in accordance with specific protocols
  • Upgrades and updates on old analytical methods
Reasearch & Development

Regulatory Affairs

Regulatory affairs professionals are crucial players in drug development. They are the primary communications link between the Company and Regulatory Authorities.

Bearing in mind that pharmaceutical industry is the most regulated of all industries, AXONE® regulatory affairs department ensure the appropriate licensing, marketing and legal compliance of all our pharmaceutical developments.

All product developments we run to license for a wide range of Companies accomplish with the applicable legal frame.

Up to the final goal of gathering a marketing authorization approval, AXONE® regulatory affairs team ensure you full support in a long and complex route that begins with properly data development compilation.

Furthermore, we also advise and co-ordinate dossiers registration and approval.

Interested in our services ?

Contact us at B2B@axone.pt