Regulatory Solutions

31. Why Regulatory CMC Strategy Is Crucial To Drug Development Projects 7/12/2024

    Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.

32. 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.

33. 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.

34. Inspection Readiness 6/18/2024

    Learn how your company can enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.

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

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

36. 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).

37. 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.

38. Promotional Materials And Compliance Activities 4/29/2024

    Learn more about comprehensive services for global promotional material review, compliance, and validation tailored to the needs of pharmaceutical and medical device companies.

39. Strategic Regulatory Operations 4/29/2024

    Experience seamless regulatory operations with comprehensive submission management from planning to delivery. Ensure compliance and efficiency with expert teams and technology-driven solutions.

40. 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.