Mon - Sat 09am - 07pm, 
Regulatory Services
Regulatory Services
Leonides provides the global life sciences industry with consulting services and solutions to support regulatory affairs operations and strategy. We specialize in helping our clients reduce cost and time to market by providing flexible, information-based services. With regulatory expertise that spans all types of products, our global regulatory consultants apply up-to-date robust regulatory intelligence to support product lifecycle management and submission strategies. Our blended onshore & offshore model can be tailored to meet each client’s particular needs. Benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiencies, lowered cost and ongoing regulatory compliance.
CMC Submission Content Development
Author, review and publish original IND, NDA, BLA, DMF, and ANDA applications, amendments and supplements. Create or assist with the refinement of regulatory strategy.
Investigational New Drug (IND and IMPD) Preparation and Submission
The overall quality of an investigational application is largely dependent on the degree to which the requirements of the Agency regulations and guidance documents are met; the quality of data and the clarity of the presentation; and the strength of the positions (interpretations and conclusions) made in the submission.
New Drug Application (NDA) 505(b)(1) Preparation and Submission
Leonides integrated regulatory solutions are designed to enhance the quality, organization and completeness of Agency applications. At every stage, we ensure that four key criteria are met.
Strategic Partnerships to optimize your Regulatory Processes, drive First-Time-Right Submissions, and enable Life Cycle Management
End-to-End regulatory services that ensure proactive compliance and drive operational efficiency
With today’s ever evolving regulatory environment placing increased emphasis on Patient Safety, we successfully partner with our clients to navigate the landscape and ensure Patient Safety. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices. Learn more about our End-to-End Regulatory Services.