Regulatory Solutions
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An Introductory Guide To Clinical EU Qualified Person (QP) Services
10/3/2022
PCI's team of qualified persons assume responsibility for all stages of the process, safeguarding patients including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.
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Medical And Regulatory Consulting: Aligned To Your Protocol-Specific Needs
9/29/2022
Novotech’s medical and regulatory consulting team offers full range of pre-clinical, regulatory affairs support, medical and pharmacovigilance consulting services.
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TrialScope Disclosure Services Workshops
9/26/2022
Our advisory workshops enable sponsor teams to prepare for CTIS and beyond, ensuring that they implement best practices. Workshop topics include high-level trends and hands-on plain language summaries, data anonymization & redaction, and transparency policies & SOPs.
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NDA/MAA Preparation Survival Guide: Overcoming Data Analysis Hurdles
9/9/2022
Read how a biostatisical programming team's ability to strategically migrate and produce clinical trial data outputs in submission-ready format represents a key opportunity to reduce timelines without sacrificing data quality.
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Bringing Life-Changing Therapies To Patients Everywhere
9/9/2022
Veristat is proud to have supported the preparation of 76 marketing applications (NDA, BLA, MAA, etc) that are now approved for patients.
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Regulatory Consulting & Planning For Clinical Development Success
9/9/2022
Regulatory planning for clinical development programs starts before and continues after Investigational New Drug (IND) application prep. As you look to transition from lab to clinic, Veristat can help.
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NDA/MAA Preparation Survival Guide: Managing Operational Complexities
9/8/2022
While all marketing applications are unique, there is no doubt they share common threads. Understanding each individual project’s complexities in advance can help teams create effective approaches for planning, mid-stream adaptation, and final submission.
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NDA/MAA Preparation Survival Guide: Three Guiding Principles
9/8/2022
No two marketing application (NDA, BLA, MAA, NDS, jNDA, etc.) projects are ever the same. From our years of experience preparing more than 120 marketing applications, Veristat has learned there are three constants you can count on.
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Balancing Compliance Among The Shifting Sands Of Pharmaceutical Data Privacy Regulations
8/26/2022
Maximize compliance, increase revenue potential, and improve patient safety by leveraging proven technology.
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End To End Safety Solutions
8/26/2022
As one of the world's largest and most experienced safety and pharmacovigilance (PV) organizations, IQVIA brings extensive domain expertise and deep regulatory intelligence to every engagement.