Strategic Consulting
Therapeutic regulatory strategy and planning.
01
Execution Services
From participating in agency meetings to turnkey filings.
02
Ongoing Support
Providing post-approval regulatory consulting services.
03
Our services
Good Support Team
We deliver deep real-world global regulatory affairs expertise and hands-on support for:
Small Molecule Drugs
provides consulting support across all phases of the regulatory pathway for small molecule pharmaceuticals.
Biological Products
provides consulting support across all phases of the regulatory pathway for biological products, including biosimilars.
Vaccine Development
provides consulting support across all phases of the regulatory pathway for vaccine development.
Advanced Therapies
provides consulting support across all phases of the regulatory pathway for advanced therapies.
Have products in your lab?
Find out how it works and ask any
questions you may have.
questions you may have.
looking to bring to FDA?
Make our specialists an extension of your team.
From the application for IND (Investigational New Drug) in the United States to the submission for listing.
One-stop service includes the design and writing of all application materials.
What We Offer:
A full-service partner for the entire product development lifecycle.
Our Team
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Testimonials
What Our Client’s Say
pricing Plans
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