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1 min read

Regulatory Publishing Expertise for an Efficient NDA Submission Process

Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing regulatory publishing expertise for a new therapy being developed for the acute treatment of schizophrenia or bipolar disorder-associated agitation. This...

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1 min read

Early Development Challenges in IND Applications

There is much for companies to consider before submitting an investigational new drug (IND) application to FDA. Planning, collecting the appropriate data, and effectively communicating with regulatory bodies can all help companies overcome challenges in...

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4 min read

Regulatory Guidance Monthly Review - August 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

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1 min read

Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...

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4 min read

Regulatory Guidance Monthly Review - July 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

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1 min read

Turning an SPA rejection into BLA Submission Success

Veristat supported a Sponsor from SPA rejection to BLA submission, bringing strategic expertise to a small client team tackling their first clinical stage program for a novel ophthalmic therapy.

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4 min read

Regulatory Guidance Monthly Review - June 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

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1 min read

On-Demand Webinar: Natural History Study for Ultra-Rare Diseases

Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”? 

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5 min read

Regulatory Guidance Monthly Review - May 2022

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device...

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2 min read

Regulatory TOPRA Webinar: Latest Regulatory Experiences

Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...

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