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Few industries are regulated as heavily as the pharmaceutical industry. Bringing a new product to market can take years and requires monumental effort. 3E™ stands ready with a comprehensive suite of products and services that can create efficiencies, support product stewardship, mitigate supply chain risk and improve compliance - ultimately shortening the time to get a product on the market.
Mitigating supply chain risk
Understanding what products are made of, the regulatory status of products and components, and the origin of products form the basic building blocks for managing regulatory obligations, communicating to key stakeholders and mitigating risk in your supply chain. 3E can help you:
Powerful tools for R&D and product stewardship
While compliance affects the entire manufacturing organization, product compliance expertise, information and data usually exists in silos, spread across several business units throughout the organization. With 3E as your single trusted source for global expertise and compliance solutions you will be able to proactively anticipate and manage regulatory obligations. You can:
- Research the EHS effectiveness of raw materials and finished products
- Research how substances used are regulated in the markets in which you manufacture and sell your products
- Identify the potential existence of banned chemicals in your inventory
- Analyze the chemical makeup of products to identify less hazardous alternatives
Flexible options for creating SDSs
For drugs or products that require an SDS, 3E has services and tools to facilitate the creation and distribution of compliant hazard communication documentation. Our products and services can help you:
- Produce SDSs and labels for finished products, including exposure scenarios and extended SDSs
- Facilitate appropriate classification and re-classification and labeling of substances to comply with GHS / CLP
- Ensure downstream customers receive / have access to your products' SDSs and emergency response contact information
- Provide an emergency contact phone number to publish on your SDSs
Keep track of what's in your lab
The nature of testing and lab research requires the use of hundreds, even thousands, of raw materials or compounds in small quantities. This makes it especially challenging for pharmaceutical companies to comply with requirements to have an SDS for every product used in the workplace. While not all products used in the lab require an SDS, pharmaceutical companies certainly find value in having access to the information found on their raw material SDSs when the time comes to document everything that goes into their finished products.
3E can alleviate much of the burden by offering a highly secure web-based application with supporting services that include obtaining, indexing and maintaining SDSs for all chemicals in the lab environment. In addition, 3E can feed raw material SDS data directly into a chemical inventory management system, such as CISPro, SciQuest, Kelaroo, or others, which can significantly streamline the management of chemical data by centralizing it into a single repository.
Ensure compliant shipments
On top of regulatory requirements for the safe transport of products, pharmaceutical companies often have extra requirements to consider, such as refrigeration or temperature control. 3E can alleviate much of the burden from a regulatory perspective. Find out how we can:
- Ensure products can be shipped using preferred mode of transport and do not contain any ingredients subject to import or export compliance requirements
- Provide guidance to employees to ensure proper markings, labels and documentation