Compliance

PRODUCTS

  • The most widely trusted solution for clinical trial disclosure management

    Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.

    Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.

  • Implement Software Solutions that Support and Enhance Your Mission

    Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.

    As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.

  • Precise, Complete, and Ultimate Detection.

    A premium dual energy x-ray inspection system offering outstanding detection of hard-to-find, low density contaminants, in a variety of applications. Available in standard and custom configurations

    Detect Hard-to-Find Contaminants

    Capable of detecting hard-to-find contaminants in a variety of applications. Offering clarity and precision in complex areas of product inspection.

    Enhance Product Quality

    Achieves outstanding product quality using advanced levels of foreign body detection of low-density contaminants in overlapping products.

    Increase Productivity

    Clever design combined with an intuitive user interface to create user-friendly systems that increase uptime and boost productivity.

  • Natoli Scientific takes pride in its comprehensive USP<1062> Tablet Compression Characterization services, tailored to address the complexities of tableting in pharmaceutical manufacturing. Staying true to the parameters outlined in the United States Pharmacopeia (USP) Chapter 1062, our approach meticulously evaluates tablet compression behaviors. By thoroughly characterizing the compression profile, we can pinpoint the optimal compression force required to form a cohesive tablet without applying undue stress that could lead to capping — the separation of tablet tops during or after the compression phase.

  • The LabAlert™ wireless laboratory monitoring system is designed to provide secure, real-time oversight of critical lab equipment and environments. This cloud-based platform enables centralized monitoring of temperature, humidity, and CO₂ levels across single or multiple facilities, with customizable alerts delivered via web or mobile app. The system supports FDA 21 CFR Part 11 compliance and eliminates manual data logging with secure, centralized recordkeeping. Easy to install and scalable, LabAlert also includes tools for preventative maintenance tracking and cost management.

WHITE PAPERS AND CASE STUDIES

NEWS