Facilitating Domestic and International Product Registration with PLM Software

Daniele Camanni is Trace One's Director of Professional Services, North America 

Registering new or updated products through the EPA, state agencies and international regulatory bodies create multi-year, overlapping projects—all of which require ample amounts of documentation.

With multiple employees working to register different product lines for different countries, R&D and regulatory departments are often chasing a tremendous paper trail or digging through Excel lookups to stay on top of registration dates and timelines. When it comes time to re-submit a product formulation, internal resources are often wasted on connecting product formulation steps to product registration needs.

Trace One’s formula-based Trace One Devex PLM system provides one system that can connect formulation development to registration requirements, compile templates for multi-country and state spec sheets and track every change throughout the lengthy product registration cycle.

Create Complete Formulation Data Prior to Registration

Trace One’s formula-based PLM tool Trace One Devex PLM helps ensure that you’re using approved ingredients at the very start of the R&D and ingredient management process.

The Trace One Devex PLM system simplifies the pre-work of product registration by keeping product planning details and facilitating ingredient, formula, specification and finished product management in one place. Ingredient and formula templates standardize the process of compiling complete product data and form a foundation for building registration packets once products are finalized. 

Prior to registration, Trace One Devex PLM provides:

• Drill-down formula ingredients and formulas for complete formula transparency
• Approval and activation steps built around proper approved ingredient percentages and other properties
• The ability to create multiple product revisions for different markets and registration needs
• The ability to reformulate products if approved ingredients are not available or change

Quickly Build Registrations Packet for Federal and State Registration

Once formulations have been set, Trace One’s Trace One Devex PLM provides templates for Confidential Statement of Formula (CSF) needed to create and submit EPA registration packets. 

CSF templates enable you to pull in product data you’ve already created during the product life cycle and automatically fill in registration fields for:

• Ingredient type and percentage
• Ingredient supplier
• Certified weight limits
• Ingredient use (toxicant, active ingredient, solving, emulsifier, etc.)
• Other physical and chemical characteristics
• Manufacturer details and more

Trace One Devex PLM links registration packets to ingredient and formula objects, creating a comprehensive view of how product data aligns with EPA requirements and forming a complete overview of both the specific ingredient details of the formula being registered and how the formula was created and modified during development. Once the entire registration packet is completed in Trace One Devex PLM, the files can be exported and submitted to the EPA for approval.

Trace One Devex PLM also simplifies the process of registering both test and active products with separate state regulatory bodies. Built-in reporting tools automatically create a specification sheet for different state renewal forms needs, which can be customized to the exact formatting needed for each registration. When the state releases a list of products with upcoming registration expiration dates, R&D and Chemistry departments can easily reference back to previous documentation and quickly update product renewals. 

Streamline Multi-Country and Sub-Registration Submissions

Beyond EPA registration, keeping track of global product registrations in each country where your products are distributed quickly becomes a maze of product and regulatory variations that impact ingredient sourcing and production.

Your company needs to stay ahead of ever-evolving country-specific rules, create product revisions that differ by tiny ingredient percentages and track the formulas or labels that are distributed by other brands. Institutional knowledge is often just not enough to keep all the specification sheets and dates straight. 

Trace One Devex PLM provides one comprehensive system for creating and tracking multi-country registrations and product variations, enabling companies to create international registration packets for products already registered and approved in the US without starting from scratch. 

Trace One Devex PLM helps facilitate: 

• International registration. Create registration packages for products that need to be submitted as separate products with non-US regulatory agencies.
• Third-party registration. Quickly compile documentation and provide a complete list of ingredient data to outside registration holders that may be facilitating the product registration process in a specific country.
• Sub-registration for re-branded products. Facilitate both the domestic EPA registration process and provide approved product data to both the secondary brand and establishment/filler that will be rebranding, relabeling and re-registering a product in a different market. Keep an accurate list of each product that has been sub-registered by an outside entity and all sub-registrations that are available and active for certain products. 

By linking product variations together and attaching related registration documents, your company can enable multiple departments to see how each item relates to original product formulas and how to integrate upcoming domestic and international regulatory changes into your product formulations for each country where you manufacture or distribute goods.

Update and Track Registration Status in One Place

Once registration packets have been sent to the appropriate regulatory agency, Trace One Devex PLM provides a status field that can be updated to note that product documentation has been submitted for registration.

Manual status updates can be changed throughout the registration cycle, with options for Submitted, Pending, Active or Rejected. Status fields keep the entire team immediately informed of where products are in the registration process at any time, provide direct access to all submitted paperwork and prompt next steps to complete the registration process.

View Complete Registration History Across Working Groups

Chances are, multiple individuals or teams with your regulatory department own different areas of registration for the same product(s). One person may be focused on state registration, another on EPA registration, someone else on a completely different area such as PMRA registration and so on.

With Trace One Devex PLM, employees across the R&D and Regulatory groups in your company can see and access a complete history of registration information so they don’t have to rely on siloed knowledge to understand where products are in the registration cycle. Integrated search abilities across product lines and status fields make it clear which stage of the registration process a product may currently be in and the status of product renewal, helping your team can take quick and informed actions around product registration.