An initial Investigational New Drug (IND) or Clinical Trial Application (CTA) submission, New Drug Application (NDA), Biologics License Application (BLA), Marketing Authorization Application (MAA), or other marketing application submission is a significant undertaking. A large, diverse team, numerous tools, planning, and processes must work together in harmony for a successful outcome. Complexity, risk, time, and costs typify every regulatory submission. Without careful planning, execution and the ability to navigate unexpected challenges, your submission may fall off track.
Keep your submission on track with Certara’s dedicated submission leads who have extensive experience advising clients and leading projects to submission and approval. Our submission leads all have more than 20 years of experience in significant submission leadership roles for biopharmaceutical companies. Supporting them is a pool of more than 200 expert project managers, regulatory writers, editors, and publishers, allowing us to build the right team for your product and submission.
“You may have seen the announcement that the FDA has accepted our NDA filing. I just want to say, thank you to each of you and everyone else at Certara who helped us get to this point. There’s more to come, but this is a big deal for us and soon for patients. We couldn’t have done it without you.” –Vice President, Program Management at a biopharmaceutical company
Robust submission expertise with a proven record of success
- More than 96% of 300+ submissions were approved
- 100% of 252 regulatory submissions over the past five years were delivered on or ahead of schedule
- Supporting more than 50 submissions per year now across all submission types, therapeutic areas, product types, and geographies
- Expert in designing, planning, and delivering to increasingly expedited submission timelines with parallel authoring
- Accelerated, Emergency Use Authorization, Fast-track, PRIME, and Breakthrough Therapy Designations
- Extensive experience with rare/orphan disease submissions (64 in the past 5 years)
- Global submission preparation and leadership focused on the incorporation of regional regulatory requirements
- Planning, strategy, and delivery expertise on simultaneous submission across US, EU, and Canada
- Experience in leading successful submissions in most major markets, as well as South America, Africa, and Eastern Europe
As key opinion leaders, Certara’s submission leads speak regularly at major industry events such as DIA Annual and AMWA’s Medical Writing and Communication Conference.
Regulatory writing to expedite your submissions
When it comes to regulatory writing and medical writing, our team of highly qualified writers includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory).
Industry best-in-class SOPs drive quality, while dedicated QC functions and integrated writing teams reduce reviewer comments and speed time to completion.
Regulatory submission guidance
Our submission leads and project managers are experts in applying project planning and management tools to accelerate and ensure successful delivery, with a state-of-the-art SmartSheet timeline and content plan tool for tracking and reporting progress.
- Early creation of overall messaging including labeling, storyboarding, and a project style guide ensure consistency throughout your submission
- Guidance on the best possible presentation of your product and data to regulatory authorities
- Support for pre-submission meetings with health authorities, including content and format interactions on pooling strategies and provision of datasets and CRFs
With a career spanning more than 30 years in the pharmaceutical industry, Steve has extensive experience across regulatory writing, consulting, and project leadership roles. He has successfully supported projects from discovery through approval and life cycle management, including holding significant roles in more than 75 submissions and, in several cases, leading the entire submission team, overseeing all documentation from Modules 1 through 5, publishing, and transmission to Regulatory authority.
Dr. Bowlby has over 25 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many New Drug Applications, Biologics License Applications, and Investigational New Drug (IND) submissions to the Food and Drug Administration and European Medicines Agency. Dr. Bowlby has led the authoring of Investigator’s Brochures (IBs), clinical study reports (CSRs), clinical summaries and overviews, briefing packages, and other regulatory documents. Earlier in his career, Dr. Bowlby planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. His therapeutic areas of expertise include ophthalmology, neurology, psychiatry, and chronic pain. Dr. Bowlby has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.
With a career spanning more than 30 years in the pharmaceutical industry, Steve has extensive experience across regulatory writing, consulting, and project leadership roles. He has successfully supported projects from discovery through approval and life cycle management, including holding significant roles in more than 75 submissions and, in several cases, leading the entire submission team, overseeing all documentation from Modules 1 through 5, publishing, and transmission to Regulatory authority.
Dr. Bowlby has over 25 years of experience in the clinical research and drug development industry. During the last 10 years, he has led many New Drug Applications, Biologics License Applications, and Investigational New Drug (IND) submissions to the Food and Drug Administration and European Medicines Agency. Dr. Bowlby has led the authoring of Investigator’s Brochures (IBs), clinical study reports (CSRs), clinical summaries and overviews, briefing packages, and other regulatory documents. Earlier in his career, Dr. Bowlby planned and wrote numerous biomedical manuscripts, posters, and slides regarding his scientific research and postdoctoral work at Harvard Medical School. His therapeutic areas of expertise include ophthalmology, neurology, psychiatry, and chronic pain. Dr. Bowlby has an expert understanding of drug discovery and development approaches used in the current biopharmaceutical environment.
