Quality and Compliance Services

Endeavor Consulting Group’s company culture is built on providing simple solutions to complex problems.

 

With years of industry experience, the team at Endeavor is able to bring a broad and unique set of capabilities to bear in working with Life Sciences companies improve the quality and compliance of their business operations.

 

Our specialized experts are here to help your organization adapt to those changes by supplementing your team and supporting your business in order to achieve better compliance at reduced costs.

Click below to learn more about our Quality and Compliance services:

  • Deploying quality IT systems, from design to configuration, integration to validation.​

  • Assessment and improvement of your company’s quality management systems and ability to adapt to change over periods of growth.​

  • Inspection readiness training, to prepare companies to avoid, address, and respond to inspection observations.

 

Applying Lean & Six Sigma to build Compliance

As external consultants, we bring two elements that are essential to helping companies improve their processes.

First, is a deep understanding of the functions and related regulations within life sciences companies.  We have experience across quality, clinical, manufacturing, logistics, and regulatory functions.  So we bring a wealth of knowledge and best practices to our clients.

Second is a rich lean and six sigma tool set.  We can apply these tools such as 5S, value stream mapping, Kanban, Kaizen to our clients.  

Third is a pragmatic and structured approach to documenting and training the new procedures that allow improved adoption and maintenance

 

SOP Reduction

As pharmaceutical & medical device companies grow, their documentation increases at an even higher rate.  Whether it is due to changes in regulations, increased scope of the organization or as corrective, these documents get more numerous and complex. 

  

The number of these documents makes it harder to be compliant because they are too complex to follow. These documents also create an undue burden to train and maintain all those documents.

There is a better way.

  • Simpler and clearer processes reduce the potential for compliance failures

  • Clarity and transparency of cross-functional touchpoints, roles and responsibilities across the organization

  • More streamlined and manageable documentation portfolio resulting is less cost and effort to maintain

  • Reduced training load

  • Reduced internal and external audit risk

 

Prototyping

From concept to drawing to rapid prototype and finally to finished photo ready models, Endeavor can provide all of your prototyping needs. We will partner with you in the process of driving from “What can it be “ to final concept that will bring your packaging to life.

Services that we offer include:

  • Conceptual renderings to explore the “what ifs” across an array of concepts.

  • 3D CAD modelling

  • Rapid 3D Prototype modeling including Stereolithography (SLA), Fused Deposition Modeling (FDM), and Selective Laser Melting (SLM).

  • Digital print technologies

  • Photo ready models 

 

ISTA Certified e-Commerce Testing

Endeavor offers International Safe Transit Association (ISTA) testing. Endeavor will provide certified ISTA testing including the 6 Series Amazon tests. Our customers find benefit in ISTA testing because it ensures that your packaging and product is protected against the rigors of e-Commerce channel distribution. Testing enables designs are also optimized for cost, speed to market and environmental sustainability.

There are a number of common ISTA testing standards that can be used as a preliminary verification method in packaging development.

  • ISTA 1 Series: Non-Simulation Integrity Performance Tests

  • ISTA 2 Series: Partial Simulation Performance Tests

  • ISTA 3 Series: General Simulation Performance Tests

  • ISTA 6 Series: Member Performance Tests

  • ISTA 7 Series: Development Tests
     

 

Fulfillment Requirements & Capabilities

Endeavor will determine your fulfillment needs and provide a the various supply chain solutions to simplify your e-Commerce needs. Our flexible supply chain solutions will be able to adapt to ever changing consumer, retailer and brand needs.

Whether your sales include wholesalers, third party retailers, or direct-to-consumer requirements, Endeavor will provide the solutions to meet them. We can provide scalable supply chain solutions that include new product offerings to bundling existing products to customer required offerings. All with cost optimization and consumer experience at the forefront of each solution.

Get in touch about your packaging needs

Phone: 908.625.0189

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303 W. Lancaster Ave., Suite 300, Wayne, PA 19087