Regulatory Compliance Solutions

  1. Technology Transfer And Commercial Manufacturing Of Tablets And Capsules 10/30/2023

    Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.

  2. Compliance Program For EU Annex 1 Container Closure Requirements

    Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.

  3. Class 2 Biological Safety Cabinet 8/29/2023

    The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.

  4. Bioproduction Regulatory Consulting Capabilities 12/20/2022

    Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.

  5. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).

  6. Minimizing Uncertainty Throughout The Development Lifecycle

    Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.

  7. Manufacture High-Quality Products With Streamlined Compliance 6/26/2025

    Manufacture high-quality products with streamlined compliance.

  8. Out Of Specification (OOS) Software For Life Sciences 8/23/2021

    The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  9. 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.

  10. Regulated Document Review 3/24/2025

    Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.