Quality control support services

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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.