Regulatory Services Case Studies

Outsourced Non-Core Regulatory Function

Fortune 50 Chemical Manufacturer

Challenge:

A large conglomerate chemical company was looking for a more proactive and efficient way to manage their supply chain regulatory data without burdening their upper-level regulatory employees. This is a company with thousands of raw materials who continuously adds new vendors, reformulates and develops new products, and makes acquisitions.

Solution:

Pace Analytical Product Regulatory Services worked closely with the client to define a customized process to collect, validate and organize their data. To ensure quality and consistency, Pace implemented standard operating procedures (SOPs) and quality control measures validated through their ISO 9001:2008 quality system.

Pace continues to work both onsite and offsite to manage and maintain this proactive regulatory process, providing the client with monthly metrics to ensure that deliverables are met. With hundreds of vendor contacts and established SOPs, this team operates accurately and efficiently.

Result:

The client’s supply chain data management is now handled in a cost effective, proactive manner, allowing their employees to focus on core regulatory activities. This vital information is available at the client’s fingertips in a way that is useful for them.

Consulting and Outsourced Regulatory Function

Mid-Sized Coating Company

Challenge:

A mid-sized global coatings company was operating with a very reactive regulatory program, which resulted in delayed shipments and increasing legal risks. No systems were in place to collect, validate and organize supply chain data, update MSDS documents and labels, ensure compliance in global markets or respond to client inquiries for information.

Solution:

Instead of investing in full-time staff, which required a substantial training investment, the company outsourced the regulatory function to Pace Analytical’s Product Regulatory Services group. Pace experts worked with the company to develop a strategic plan to meet their long-term regulatory needs. They aided in selecting a chemical management software program and then provided an on-site, knowledgeable user to populate their system, which included collecting missing data. The company also chose to outsource the conversion of their MSDSs to GHS compliant documents, which Pace is currently doing remotely from their Minneapolis facility. Further, the company now utilizes a Pace Senior Regulatory Specialist to meet ongoing customer-specific regulatory compliance inquiries.

Result:

This coatings company has eliminated interruption of product sales by becoming proactive instead of reactive. They now have a functional database populated with complete, validated regulatory supply chain data which is vital for downstream use. They will meet the OSHA HazCom requirements for updated labels and SDS documents. The client is now in a position to easily keep their database and documents current and organized, but will continue to use Pace as a resource for more complex regulatory issues.

Consulting

Start-up Green Chemistry Company

Challenge:

A start-up chemistry company developed a novel chemistry for the green market. While they have plenty of expertise in their field of chemistry, they did not have knowledge of complex regulatory requirements necessary to bring their product to market. Since they are a start-up company, they are simply unable to make the cost commitment to a full-time, experienced regulatory employee at this time.

Solution:

The company used Pace Analytical’s Product Regulatory Services group to act as their regulatory compliance experts. Pace provided the SDS authoring and label text, new chemical registration assistance, testing recommendations and data interpretation. They helped with REACH preparation, which will allow the company to sell in the European Union, as well as site permitting, DOT permitting, DHS support and more.

Result:

Pace navigated this client through the launch of their products and jump-started their regulatory program. Pace is still available to them for ongoing issues as they arise.

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