We recognize that regulatory strategy should be different for each product and indication and should be formulated with your business objectives in mind.

AllTurio advises life sciences companies on effective strategies to develop early phase, innovative technologies, with the prospect of a long-term service to get their products to market. The output of our strategic road map provides a pathway suitable to navigate the FDA and EU agencies requirements.

Our consultants have also extensive experience in generic, biosimilar, branded generics and hybrid application development.

ANDA and 505(b)2 expertise:

• Regulatory strategy for a generic or hybrid pathway application
• Provide check lists for documentation
• Write/review overall summaries
• Compile the application