Regulatory Solutions

  1. Clinical Pharmacology Studies For NDA Filing 6/18/2024

    Need help with inclusion/exclusion criteria for your Phase 2/3 protocol or an unexpected FDA post-marketing amendment? Altasciences offers reliable solutions with a quick start-up.

  2. Moving In Unison: Proprietary Scheduling Platform 6/18/2024

    Join us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.

  3. Regulatory Lifecycle Management (LCM) Services 6/3/2024

    Managing regulatory compliance for mature products while driving growth through new product development requires careful balance.

  4. RegOps Services To Streamline Regulatory Submissions 5/28/2024

    Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

  5. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

  6. Accelerate Clinical Development With Patient-Centered Digital Measures 4/26/2024

    Discover how partnering with a trusted and experienced technology provider can help to overcome barriers associated with the collection and management of large-scale digital data.

  7. Human Abuse Potential 4/17/2024

    With over 60 HAP studies successfully conducted in the last decade, Altasciences has experience in diverse areas such as for stimulants, opioids, and sedative-hypnotics.

  8. Accelerated Clinical Trial Disclosure Starts Here 2/20/2024

    See why TrialScope Disclose is trusted by 16 of the top 20 industry clinical trial sponsors for optimizing, streamlining, and simplifying the clinical trial disclosure process from registration to results.

  9. APAC Biopharma: Bridge The Gap To The US FDA 2/8/2024

    Uncover how these regulatory and partner/outsource services are invaluable for biopharma innovators in navigating the U.S. FDA regulatory process.

  10. Safety And Regulatory Compliance Solutions 1/29/2024

    IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.