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