“Medical affairs experts provide medical and safety input into development plans, protocol design, feasibility, site selection, and Key Opinion Leader identification, working alongside clinical operations and biometrics teams from the earliest planning stages.”
“Veristat's MDs stay directly connected to patients from trial start to finish, collaborating across clinical operations, biometrics, and medical writing to ensure safety considerations are built into decisions throughout the program, not just addressed after issues arise.”
“Yes. Veristat develops, recruits, and organizes Data Monitoring Committees to review clinical data throughout the trial and help ensure patient safety.”
“Under MDR, Class III and implantable Medical Devices generally require a Clinical Investigation to evaluate safety and performance, though exceptions can apply depending on the specific device and its regulatory pathway.”
“A Performance Evaluation Report (PER) assesses existing data, including literature and equivalent device data, to establish an IVD's scientific validity and performance, while a Performance Study is a study specifically designed to confirm the IVD's analytical or clinical performance for its intended purpose.”
“A regulatory Gap Analysis identifies the difference between a device's current state of development and what's required for certification, helping define the objectives and milestones needed to reach the next goal, whether that's entering clinical stage, completing clinical evaluation, or obtaining the CE mark.”
“The CE mark is the certification required to legally market a medical device or IVD in the European Economic Area (EEA), similar in purpose to FDA clearance or approval in the US, though the two follow entirely different regulatory pathways and requirements.”
“Veristat provides clinical, nonclinical, and CMC regulatory writing support throughout the drug development lifecycle. Our expertise spans protocols, Investigator’s Brochures, Clinical Study Reports, INDs, NDAs, BLAs, MAAs, post-marketing safety reports, and many more.”
“Established SOPs and a dedicated QC review process catch formatting and consistency issues early, reducing the number of review cycles needed to finalize a document.”
“Yes. Our team has extensive experience supporting submissions to regulatory authorities worldwide, including the FDA, EMA, MHRA, and PMDA. We apply our knowledge of regional regulatory requirements to deliver high-quality submission documents.”
“Yes. Our team has extensive experience supporting submissions to regulatory authorities worldwide, including the FDA, EMA, MHRA, and PMDA. We apply our knowledge of regional regulatory requirements to deliver high-quality submission documents.”
“Yes. We provide scalable writing support, from standalone deliverables to complete submission packages and ongoing regulatory writing needs.”
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