Case Studies: Assuring Regulatory Success
We share these case studies to demonstrate our commitment to achieving your program's regulatory success.
Case Studies
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New Jersey.
A commercial stage biopharmaceutical company focused on the development of novel treatments for B-cell diseases was focused on pursuing FDA approval for a recombinant IgG1 chimeric monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS).
A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy…
A Tier 3 Sponsor called upon Certara Synchrogenix to support its rolling BLA submission, the second submission we supported for…
A commercial-stage biopharmaceutical company recently employed new team members to support the production of patient safety narratives across the primary and extension Clinical…
An American biopharmaceutical company had received a health authority request to provide safety narratives for patients meeting elevated laboratory result criteria.
In August 2020, an emerging global biotechnology company reached out to Synchrogenix, Certara’s regulatory sciences division, to evaluate the company’s status and strategic…
Gene therapy developers often have technical expertise when it comes to their product, but may not have a full understanding of regulatory writing requirements for specific document content.
In early 2020, an emerging global biotechnology company was in need of anonymization and redaction services for upcoming expected Health…
In April 2020, a leading biotechnology company required the authoring of 3,000 narratives in approximately four months across four studies for its BLA.