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FDA Support Services

NEXT Molecular Analytics provides sophisticated research and development support activities on a fee-for-service or extended contract basis. We offer comprehensive integrated project support to investigators in the biotech and pharmaceutical sectors and in this manner, we function as an extension of your own laboratory in helping you to bring their products from discovery to market.

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Contract Research Services
NEXT offers drug and diagnostic development organizations a broad range of laboratory services for bringing new products to market. We offer expertise in a wide range of technologies and analytic capabilities. Our laboratories can provide "collaborative and problem-solving
solutions" from discovery to market.

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Compliance
NEXT has expertise in core laboratory competencies and offers services under the FDA’s Good Laboratory Practices (GLP) Guidelines as codified in 21CFR 58. Selected Services are also offered under the FDA’s Good Clinical Practices and CLIA guidelines. NEXT Quality Assurance provides oversight of all regulated services. NEXT also offers non-GLP or R&D level studies. These services are offered individually or can be integrated to support product development from discovery to market.

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Protein Chemistry

  • Proteomics

  • Biochemical Analysis


Nucleic Acid Chemistry

  • Next Generation Sequencing

  • Genomics (Rx or Dx targets)

  • Bioinformatics

  • Molecular Biology Services

  • Custom Molecular Assays


Immunology

  • Immunogen / Epitope Preparation and Characterization

  • Monoclonal Antibodies

  • Polyclonal Antisera

  • Monospecific Polyclonal Antisera

  • Antibody Characterization

  • ELISA Development


Microbiology and Virology

  • General Microbiology

  • Molecular-Based Detection

  • Bio- and Food Safety

  • Assay development

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Contact us to discuss how NEXT Molecular Analytics can support you in your interactions with the FDA.

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