Regulatory Solutions

  1. CRO Of Choice For Cell And Gene Therapies 2/17/2023

    Whatever a study’s unique considerations – patients, products, process, follow-up, regulatory – Veristat can successfully get you through it.

  2. Biorasi Puts You On The Path To Successful Regulatory Approval 2/3/2023

    Every journey needs a guide. Let’s talk about an effective regulatory strategy for your next clinical trial.

  3. Expert Regulatory Filings To See Your Regulatory Strategy Through 1/18/2023

    Veristat’s regulatory publishing team offers extensive expertise across the full scope of regulatory requirements.

  4. IQVIA Regulatory Affairs And Drug Development Solutions 1/9/2023

    Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps to reduce time, cost, and risk, from discovery through post-registration.

  5. Get Expert Regulatory Consultancy For Your Clinical Trials 12/20/2022

    Novotech’s Medical and Regulatory Consulting team offers a full range of pre-clinical, regulatory affairs support, medical, and pharmacovigilance consulting services.

  6. Local Affiliate Product Services 10/31/2022

    Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.

  7. 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.

  8. 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.

  9. 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.

  10. 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.