Faster - bulk import of raw materials and formulations data; intuitive versioning and clone functionality for all specifications; automated compliance and safety analysis; one-click generation of full mandatory label content and all PIF and registrations documents in pdf; instant creation of REACH reports with calculated cumulative quantities of substance from the entire product portfolio.
Less resources - less work or no data duplication with "one specification in one place"; all specifications are linked with automated data synchronisation enabling “one to all” changes; extensive and easy impact analysis and reporting; dashboards to monitor portfolio compliance and PIF completeness; seamless real-time PIF, CPSR and label content creation and export.
Higher quality - regulatory and toxicology databases are included, kept up-to-date and managed by The Regulatory Company [TRC] with the latest (future) regulatory and toxicology data; auto-updated product compliance and safety statuses and insight at your finger tips, and "back-in time".
Reliable with Confidence - already thousands of products managed by customers and TRC in PRIMS; ensuring full transparency in your product portfolio in a “from substance to consumer unit” fashion; complementary in-house consultancy, compliance and Responsible Person services; proven success in passing competent authority inspections.
We fully support the data transfer to ensure a smooth transition, a minimum-effort implementation process, and short-term internal adoption of PRIMS.
You provide the compositional data and other structured data in bulk. We perform the data import and we make sure that your PRIMS users are properly trained. You are guided in the entire on-boarding process by one of our dedicated project managers that will be assigned to your project.
Already on the first access to PRIMS most features and reporting are immediately available, such as automated compliance status monitoring and detailed analysis per product, product composition downloads and mandatory label content briefs, 24/7 real-time compliance dashboard (including the REACH management dashboard), and where used reporting.
The document transfer and upload process is discussed in more detail to find the right balance and timing between workload and added value.
For each specification (raw material, formula, packaging component, product, multi-product kit) data and documents are managed as "one item only".
All related specification of all levels are linked to each-other. This ensures full real-time traceability for the finished product (SKU) down to the raw material and individual substances (INCI) level and back.
Each user has a named user account with a user rights profile connected to it. All activities are logged and can be traced back in time.
Each individual specification is processed through its own lifecycle (development, provisional, active, superseded, discontinued). New versions are created to develop and replace the active version.
The cloning function enables easy creation of variations of a product, for example a range of 6 shower gels with the same base formula with different colours and/or fragrances. All clones maintain the links to the raw materials and substances and all respective documentation.
Regulatory and toxicology data
The regulatory and toxicology data for the cosmetic ingredients (INCIs) are continuously managed, validated and updated by TRC and available to all users.
Whenever amendments to the regulatory data are published with or without transitional period, the data is timely updated.
Toxicology data includes toxicological thresholds for cosmetic ingredients for the relevant endpoints, and when relevant other information sources are included based on the weight of evidence approach e.g. data by CIR, EFSA, WHO, OECD etc.
PRIMS algorithms are in line with the currently applicable approach for the safety assessment of cosmetic products. If no toxicological data is available for an ingredients, a read-across in case of Quantitative Structure Activity Relationship (QSAR) or Toxicological Thresholds of Concern (TTC) may be applied as alternative. In the future, in line with the latest developments on Next Generation Risk Assessment (NGRA), PRIMS will integrate the new alternative methodologies and PoDs as they become available.
Additional (unpublished) toxicology data can be shared with TRC to be included in PRIMS after thorough evaluation at all times.
The smart algorithms alert on missing PIF data and documents, produce cumulative formula compositions per substance, highlight non-compliance and safety concerns, and provide guidance on mandatory label content.
The 24/7 real-time compliance status is not just indicating whether a regulatory threshold applies (like in many other available compliance software solutions), it is the result of an evaluation against exact thresholds that apply to the specifically chosen product category. Where applicable , the algorithms combine the sum of multiple substances for evaluation against both their individual and their combined group-thresholds. Regulatory AND toxicological thresholds are both included.
Users can easily view the portfolio compliance status, REACH compliance status, and drill down to individual product and individual substance compliance.
PRIMS includes an intuitive user interface, dashboard overview with product portfolio compliance status and easy navigation. Specifications are fully traceable back and forth through one-click navigation between raw materials, formulations, packaging components, products and companies (suppliers), and where-used reports are generated and exported in spreadsheet format in a few seconds.
PRIMS has been developed with a 100% focus on regulatory requirements and processes, and to quickly produce the relevant output documents and reports such as the CPSR, Cumulative Product Composition (exact or ranges), and the Regulatory Content Brief (mandatory label content).
Documents and reports are available in PRIMS at all times, are quickly (re-) generated to adjust for any changes, and ready for export/download to all users.
The REACH management dashboard presents a real-time overview of all substance-supplier combinations that require verification of REACH registration compliance.
To manage importer obligations, PRIMS algorithms calculate and present substance-supplier combinations where the annually imported quantity surpasses the 1.000 kg threshold, by at least one individual importer, and where the substance is not exempted.
By changing the selection criteria (calendar year, region, local manufacturers), the dashboard overview is modified to meet your needs.
IT NEVER HAS BEEN THIS EASY!
PRIMS enables the regulatory team to work faster and more efficiently, and adds significant quality, continuity and confidence to the regulatory function. The compliance and safety results are highly reliable.
Once operational (within 4-8 weeks), total resources spent on regulatory processes are significantly reduced with up to 40%, in particular on PIF management, and (continuous) compliance and safety assessment.