New England Consulting LLC
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New England Consulting LLC

Signed in as:

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  • Home
  • About
  • Services
    • Strategic Consulting
    • cGCP & cGMP Quality
    • IT Expertise and Support
    • Project Management
    • Quality control support
  • Contact

Account


  • Bookings
  • My Account
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Quality and Operational Support

Quality and Operational SupportQuality and Operational SupportQuality and Operational Support

Experienced and Personalized Consulting Services 

Pharmaceutical, Biologics, Cell/Gene Therapy and Medical Device Industry

Quality and Operational Support

Quality and Operational SupportQuality and Operational SupportQuality and Operational Support

Experienced and Personalized Consulting Services 

Pharmaceutical, Biologics, Cell/Gene Therapy and Medical Device Industry

What we do and why

Who is New England Consulting LLC?

While spending years in private and public pharmaceutical, biologic and medical device  industry, employing countless consultants and consulting companies, it was a challenge to achieve company objectives in a timely, simple, efficient and logical manner. We were where you are today and shared the same challenges. 


Consultants and Consulting companies didn’t take the time to understand the needs of the company. Many systems created, remediated, or enhanced resulted in complex, complicated processes that were inexecutable with the available resources and infrastructure. We knew there was a better way of delivering superior consulting services in budget, on time, every time considering and leveraging the infrastructures already in place. That’s how 

New England Consulting LLC was born. 


We strive to cultivate transparent and collaborative partnerships with internal and external stakeholders to become a trusted resource on the analysis and interpretation of cGCP and cGMP requirements and health authority regulations.


We listen to you, we gain a deep understanding of your needs and objectives, and together we can create a plan to achieve your objective in a way that will be both timely and effective. We understand the resources available; we will measure our progress and success with periodic metrics and updates, ensuring full transparency and accountability of every project. We will work for you and with you to ensure we meet and exceed your expectations.

SERVICES AT A GLANCE


  • End to End CMC, GMP/GCP Quality, Project Management, and IT Expertise,
  • Quality Support including all Compliance functions (i.e. Auditing/Inspection Readiness including Mock inspections),
  • Quality System execution (i.e. Deviations/CAPA/Change Control), system creation, evaluation, enhancement and remediation,
  • Superior Project Management with full accountability and periodic progress reporting via metrics and KPI's,
  • Clinical Quality Assurance including site monitoring and investigation/vendor oversight,
  • Quality Control process creation and lab setup, including OOS /aberrant results investigations and implementation of LIMS or paper-based systems.


WHAT SETS US APART FROM OTHER CONSULTING COMPANIES?

  • We are adept and capable at integrating into your established organization quickly and efficiently, ensure your deliverables are met within established timeframes, 
  • we understand the need to effectively and intelligently balance and measure the cost of Quality within the realm of your business environment.  
  • We are unique among other consulting companies, as we see Quality as a business partner that should be deeply incorporated into the strategic and long range business planning.  

Let's Chat!

Services

Strategic Consulting

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cGCP and cGMP Quality Support

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IT Expertise and Support

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Project/Program Management

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Quality Control Support Services

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