Pharmaceutical

Few industries are regulated as heavily as the pharmaceutical industry. Bringing a new product to market can take years and requires monumental effort. 3E Company 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

The demand for data transparency is insatiable and unavoidable. 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. 3ESC Supply Chain Solutions™ can help you:

  • Gather information from upstream suppliers such as material disclosures, substance declarations, compliance certificates, certificates of origin and more
  • Respond to incoming customer surveys / inquiries while protecting confidential business information and trade secrets
  • Monitor new and emerging regulatory obligations and market trends and assess how they impact your products, suppliers or customers
  • Assure compliance and market accessibility for your products by identifying risk associated to products and suppliers
  • Analyze compliance status by supplier, raw material, product or obligation

Powerful Tools for R&D and Product Stewardship

While compliance affects the entire organization, typically only a few individuals fully understand and are accountable for ensuring the requirements are met. Product compliance information and data usually exists in silos, spread across several business units throughout the organization. 3E® provides R&D, product stewardship and regulatory professionals with powerful and robust tools for a number of compliance related activities, including:

  • Ensuring ingredients don't have adverse impact on human health or the environment
  • Identifying and understanding the local jurisdiction's regulatory requirements for ingredients used in finished products
  • Complying with requirements to ban restricted substances from product portfolios
  • Analyzing the chemical makeup of products to identify less hazardous alternatives

Learn more about Ariel® WebInsightAriel Integrated Content Solutions and Ariel Content Solutions for SAP®


Flexible Options for Creating Your Own MSDS / SDSs

For drugs or products that require an MSDS / SDS, 3E has services and tools to facilitate the creation and distribution of compliant hazard communication documentation. Our products and services can help you:

  • Product MSDS / 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' MSDS / SDSs and emergency response contact information
  • Provide an emergency contact phone number to publish on your MSDS / SDSs

Learn more about 3E MSDS / SDS Authoring & Distribution ServicesMSDgen® Authoring Software and Emergency Response Services.


Do You Know 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 MSDS / SDS for every product used in the workplace. While not all products used in the lab require an MSDS / SDS, pharmaceutical companies certainly find value in having access to the information found on their raw material MSDS / 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 MSDS / SDSs for all chemicals in the lab environment. In addition, 3E can feed raw material MSDS / SDS data directly into a chemical inventory management system, such as CISPro, SciQuest, Kelaroo, Enablon or others, which can significantly streamline the management of chemical data by centralizing it into a single repository.  

Learn more about our MSDS / SDS Management products and services.


Shipping Pharmaceuticals Can Be a Challenge

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

Learn more about Ariel WebInsight, Ariel Content Solutions (including SAP) and Transportation Services.