Regulatory & clinical experts help you navigate TA’s through FDA
Our experienced team knows how to guide you over the bureaucratic hurdles and red tape of therapeutic areas (TA's) and regulatory agencies to build global development programs.
From strategic pharmaceutical analysis to regulatory evaluation, we’ve got you covered.
Our knowledgeable professionals provide the insights you need, without the coordination headaches or overhead cost. We collaborate on embedded or virtual solutions by integrating seamlessly into product teams while advising senior management.
Meet our Team
Our Services
Visionary strategy. Proven-effective tactics. Innovative product-approval solutions.
Regulatory Strategy
We provide US Regulatory strategy across therapeutic areas for drugs, biologics, and vaccines, as well as combination products that include devices.
Regulatory Operations and Submissions
Our operations expertise includes document publication for all eCTD Submissions (IND, NDA, BLA).
Due-Diligence Reviews
Our regulatory & medical due-diligence reviews evaluate data for licensing candidates: regulations/guidelines, regulatory strategy/implementation/authorities, and technical data.
Regulatory Intelligence
We assess “what-if” regulations/guidelines scenarios, prepare fully justified dossiers, and jointly determine regulatory & legal status, easing regulatory compliance via consultation.
Clinical Development
Our planning & trial-design approach vets filing/submission strategies across therapeutic areas and product life cycles, transforming client assets into valuable patient therapies.
Non-clinical / Toxicology Regulatory Development
We offer preclinical ADME (absorption, distribution, metabolism, excretion), pharmacology, and pharmacokinetic (PK) strategy to help your molecule through development. We also provide regulatory guidance to ensure positive interactions with regulators.
Strategic Pharmacokinetics / Pharmacodynamics (PK/PD) Development
Develop pharmacology and PK programs for regulatory submissions across all therapeutic categories and drug development phases, including Rx to OTC Switches.
U.S. Agent to FDA
Representing international companies as designated US agent, we liaise with the FDA to resolve issues and market approvals while managing FDA database study-information input.
Knowledge. Experience. Dedication.
We excel in developing strategies, implementing tactics, and brainstorming innovative ways to obtain approval of our sponsors’ products.
Learn how we can help you
Our Clients
Rio Pharmaceutical Services has worked with more than 30 industry-leading international companies. Clients range from the vast majority of Fortune 500 pharmaceutical companies to a number of well-known venture capital groups.
Have a question about our services?
Contact us today for a free initial consultation.