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    Amplexor Life Sciences

    Amplexor Life Sciences is a software solutions provider that supports the global life sciences industry in achieving their goals by providing the most innovative content and process management solutions and the highest quality services.

    Amplexor’s suite of software solutions enables users to manage multi-lingual data, content, and documents as well as regulatory submissions, quality processes and adverse event reports across the entire product lifecycle.

    Vision & Mission

    The company operates under an overall vision of operating as an agile and efficient international provider, forming a trusted and reliable partner for global life sciences companies.

    The Amplexor product and solutions portfolio for pharma, biotech and medical device customers focuses on regulatory compliance, along with business knowledge, consultative solutions, best value delivery, and sustainable improvements.

    Amplexor solutions allow users to:

    • Reduce time to market for new products and the overall Product Life Cycle Management effort
    • Introduce sustainable compliance
    • Increase the overall quality of data, content, and documents, as well as process efficiency
    • Minimize the total cost of ownership (TCO) for IT solutions

    Products & Services

    Amplexor specializes in offering holistic Regulatory Information Management (RIM) and Quality Management System (QMS) solutions for the Life Sciences Industry.

    The Amplexor Life Sciences Suite provides a complete range of solutions designed to seamlessly address the real end-to-end business needs, including regulatory compliance, content management, planning and tracking, product information management, submissions management and publishing, labeling management, regulatory analytics, quality control and assurance, document management, process management and quality analytics.

    Amplexor Life Sciences Suite includes the following solutions:

    • R&DExpert
    • SubmissionExpert
    • RIMExpert
    • ProductExpert
    • LabelExpert
    • QualityExpert

    Some of the key benefits AMPLEXOR Life Sciences Suite brings:

    • Improved operational efficiency through use of a consistent and user-friendly enterprise collaborative environment, decreased manual steps, reduced data entry and increased data quality due to powerful automations.
    • Improved information flows through end-to-end business processes coverage supported by one holistic solution suite.
    • Incorporated data standards based on common master data model built on top of IDMP and other foundations.
    • Lower complexity and sustainable compliance due to established enterprise-wide standardization and pre-validated solution.
    • Single source of truth achieved by sharing common master data model, as well as reusing data and content across all solutions and processes.

    Amplexor Life Sciences Suite is built on top of the Amplexor Compliance Foundation platform. This unified platform provides a common set of rich capabilities which enable management of data, content and processes across all solutions in a familiar user interface. It is fully flexible to support constantly evolving regulatory and specific business needs. Amplexor Compliance Foundation contains a powerful automation engine which drives complex process automations, migrations and integrations. The platform has a scalable architecture and suitable for both cloud and on-premises deployment models.

    Strong capabilities built in Amplexor Compliance Foundation enable our customers to:

    • Replace outdated technology by standardizing on top of a single unified platform
    • Reduce Total Cost of Ownership
    • Become better prepared for rapid changes that future will bring

    AMPLEXOR Life Sciences Suite is available for both cloud and on-premises deployment models.

    Amazon Web Services (AWS) based AMPLEXOR Life Sciences Cloud represents an immediate jump-start option for private cloud deployments. Private cloud provides best of both worlds – complete separation of data and solution layer while leveraging the benefits of reliable and scalable common cloud infrastructure and platform services. Combined with subscription model, this allows full flexibility and dramatically reduces the required investment.

    AMPLEXOR solution offering is complemented with a full set of services:

    • Implementation Services
      • Strong technical and business consulting team
      • Optimized implementation methodology
      • Proven delivery framework
      • Global partner network
      • Validation accelerator package
    • Training Services
      • Role-based training
      • Computer-based training
      • Standard training packages and materials
      • Customized training
      • On-line and classroom training
    • Integration Services
      • Standard connectors to business line applications and collaboration platforms
      • Standard integration API
    • Migration Services
      • Universal configurable migration engine
      • Migration accelerators
    • Support Services
      • 24/7 service desk
      • Managed Services
      • Flexible Service Level Agreements

    Company History and Structure

    Amplexor Life Sciences has evolved from the mergers of several companies whose collective histories date back to 1987. The years after 2014 saw rapid growth and further geographic expansion to the USA, Europe, Middle East and Asia.

    Amplexor recently became a member of the Acolad global family of companies, strengthening its worldwide presence.

    The leadership team includes Elvis Paćelat, Executive Vice President at Amplexor Life Sciences, a business and technology executive with more than two decades of international experience in the Life Sciences market.  As Amplexor’s EVP Life Sciences, Mr.  Paćelat is responsible for driving the corporate strategy and market success of the Amplexor Life Sciences solution business as part of a corporate commitment to delivering benefit for clients, partners and shareholders, whilst supporting client-centric strategies and spearheading groundbreaking innovations.

    Quality, Regulatory and Standards

    As a company specializing in quality control (QC) and quality assurance (QA), all of Amplexor’s systems and processes are conducted to the highest standards.  The company is quality certified to SOC 2 (Type 2), ISO 9001, and ISO 27001 international standards.

    Its products and processes also comply with GxP, GAMP, 21 CFR Part 11, and EU Annex 11 guidelines.

    Internal quality is enforced by the Amplexor Integrated Quality Management System, which has been audited by numerous life sciences companies.

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