Regulatory Submissions
Ensuring success across IND, NDA, BLA, and MAA
Unparalleled expertise and support for biopharmaceutical companies navigating the complexities of Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), Biologics License Application (BLA) or Marketing Authorization Application (MAA) submissions.
Learn more about Regulatory Submissions
Expert submission leadership tailored to your needs
Navigating the intricate process of submitting INDs, NDAs, BLAs, and MAAs requires a skilled and cohesive team. Certara’s submission leads boast over 20 years of experience in regulatory submission leadership, driving success with a 96% approval rate across more than 300 submissions. From strategy to execution, our team ensures compliance, quality, and efficiency.
Proven track record
Over 96% of 300+ submissions approved, with 100% delivered on or ahead of schedule.
Global expertise
Experience leading successful submissions in the US, EU, Canada, and emerging markets like South America, Africa, and Eastern Europe.
Innovative tools
State-of-the-art SmartSheet tools optimize planning and reporting for expedited timelines.
Rare disease focus
Extensive experience with rare/orphan disease submissions, including 64 in the past five years.
Pioneering submission excellence
Insights on streamlining regulatory success for pre-submission meetings with health authorities.
Unmatched regulatory expertise and innovative approaches
Our offerings
IND submissions
Expert guidance for investigational drug applications.
NDA submissions
Streamlined support for new drug applications.
BLA submissions
Comprehensive strategies for biologics license applications.
MAA submissions
Global expertise in marketing authorization applications.
Meet our experts
1 / 2
Experts
Steve Sibley
Vice President, Regulatory Strategy
Over 30 years of experience leading global submissions, specializing in oncology and rare diseases.
Connect
2 / 2
Experts
Mark Bowlby
Senior Director, Global Submissions
25+ years in drug development with expertise in ophthalmology, neurology, and chronic pain.
ConnectRelated resources
View allContact us
Certara provides expert guidance and innovative solutions to streamline your regulatory submissions, ensuring success at every stage of the process. Reach out to our experienced team to discuss your unique needs today.
Proven 96% approval rate across 300+ submissions.
Over 20 years of leadership experience per submission lead.
Comprehensive global expertise across all submission types.
Start a conversation
Discover more services
FAQs
What types of submissions does Certara support?
Certara specializes in IND, NDA, BLA, and MAA submissions across all therapeutic areas and geographies.
How does Certara ensure submission success?
With a proven 96% approval rate, Certara leverages experienced teams, innovative tools, and structured planning for efficient delivery.
What is Certara’s expertise in rare diseases?
Certara has extensive experience with rare/orphan disease submissions, completing 64 in the past five years.
