New England Consulting LLC

New England Consulting LLCNew England Consulting LLCNew England Consulting LLC
  • Home
  • About
  • Services
    • Strategic Consulting
    • cGCP and cGMP Quality
    • IT Expertise and Support
    • Program Management
    • Quality control support
  • Contact
  • More
    • Home
    • About
    • Services
      • Strategic Consulting
      • cGCP and cGMP Quality
      • IT Expertise and Support
      • Program Management
      • Quality control support
    • Contact

New England Consulting LLC

New England Consulting LLCNew England Consulting LLCNew England Consulting LLC
  • Home
  • About
  • Services
    • Strategic Consulting
    • cGCP and cGMP Quality
    • IT Expertise and Support
    • Program Management
    • Quality control support
  • Contact

Quality control support services

With more than 20 years of experience in varying stages of development across numerous drug platforms (microbiome, oncology, anti-body-drug-conjugates, gene therapy, biosimilars/bioequivalents and more), we can offer you and your team all-encompassing Quality Control creation, execution and management services.  

We understand that there is a breadth of therapies, and each is unique and should be treated individually.  We have the expertise to meet your needs and achieve your objectives.  

Our skillset allows for us to work from a development arena all the way to commercial manufacturing.  We can provide the following resources (and more):

  • Documentation support: Our experience includes data review, statistical analysis of transfers and validations of analytical methods, method and standard operating procedure authoring, form design, and just about anything a QC lab needs to thrive. 
  • Stability Support: From the design of a study to the report finalization, we will execute, support and manage on-going or existing studies.  We understand the regulatory environment and expectations of regulatory agencies in this challenging space. 
  • QC and Product Management: At NEC, we can create, execute and manage QC sample processes, both via LIMS and paper based.  This includes methods, forms, logbooks, and excel/SAP designs to capture data and intelligently output reports.  We can create, execute and manage your aberrant results/OOS investigation program to comply with the ever-changing regulatory landscape.  
  • Critical Reagents Program: A compliant QC lab must have control of any specialized reagents or chemicals used in testing.  we can and have designed executed and managed several programs to capture the purchase, shipping, testing and release of critical materials in a GMP compliant manner.  
  • Method/Assay Transfer: We can provide services for any phase of method transfer, whether sending or receiving.  With our analytical development and QC experience, so we can provide a one-stop shop for transfers of analytical methods.  
  • Method/Assay Validation: Since we have experience with the validation of over 50 analytical methods, we can create, execute and manage you method validation program.  Our experience includes including flow cytometry, moisture testing, anti-coagulation assays, HPLC methods, Host Cell and Residual assays, ELISAs, Cell-based assays and more.  Additionally, we can create, execute and manage your compendia Method verifications programs and support any novel method validation.  
  • Environmental Monitoring: Whether it be  facility design, enhancement or improvement of existing EM programs, creation of sampling plans, testing recommendations, or a CTL management program, we can bring create, execute, enhance or improve your programs to ensure success.  Additionally, we have contacts at many of the major contract EM testing firms and know how to foster and nurture those relationships.  

Schedule a Consultation

Book your free consultation to discuss the needs of your company and learn more about how we are here to help!

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Reviews

"I would not hesitate to recommend NE Consulting LLC to any organization"

"Everyone at NE CONSULTING LLC was a pleasure to work with and face challenges head on."

"It would be a pleasure to be able to work with NE CONSULTING LLC again in the future."

I have worked with NE Consulting LLC  for the last year and nine months. They have brought a level of knowledge, professionalism, and humor in leading our Quality organization that was significantly impactful. I

have also received great feedback on their leadership and management skills. I would not hesitate to recommend NE Consulting LLC  to any organization.

"It would be a pleasure to be able to work with NE CONSULTING LLC again in the future."

"Everyone at NE CONSULTING LLC was a pleasure to work with and face challenges head on."

"It would be a pleasure to be able to work with NE CONSULTING LLC again in the future."

NE Consulting LLC  was a pleasure to work with. They are a hard workers and are very good at what they do. They  have extensive knowledge in Quality and Compliance and can identify and remediate compliance gaps within an organization. Mike also has a great personality, allowing him to communicate effectively

with all departments within an organization. It would be a pleasure to be able to work with NE Consulting LLC  again in the future.

"Everyone at NE CONSULTING LLC was a pleasure to work with and face challenges head on."

"Everyone at NE CONSULTING LLC was a pleasure to work with and face challenges head on."

"Everyone at NE CONSULTING LLC was a pleasure to work with and face challenges head on."

I have worked with NE Consulting LLC  on multiple projects and have found them to be highly knowledgeable in Quality Systems. They are a pleasure to work with and face challenges head on.

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