Synterex is a WBENC-Certified Woman’s Business Enterprise and disability-owned clinical and regulatory consulting firm that provides clinical development solutions.


Synterex is a WBENC-Certified Woman’s Business Enterprise and disability-owned clinical and regulatory consulting firm that provides clinical development solutions. Delivering quality regulatory documentation requires navigating an evolving landscape influenced by regulators, research committees, healthcare professionals, and—most importantly—the scientific method itself.

At Synterex, we forge lasting and meaningful relationships that flex with the dynamic nature of science and technology.

Our staffers are seasoned and dedicated, with extensive experience doing the work hands-on as well as building and leading teams. We are committed to applying our years of experience and current subject matter and technical knowledge to help clients deliver important new therapies to patients in an expedient manner.


  • Medical Writing Services

    • Briefing documents
    • Protocols/amendments (Phase 1-4, Registries)
    • IBs
    • CSRs
    • INDs
    • NDAs
    • Narratives
    • Annual reports
    • Abstracts
    • aNDAs, sNDAs, 
    • NADAs, ANADAs, CNADAs (vetrinary/animal health)
    • Assessment aids (oncology)
    • BLA
    • Breakthrough designations
    • Clinical and Nonclinical summaries
    • Clinicaltrials.gov and other trial disclosures
    • CMC writing
    • Fast-track applications
    • Integrated summaries of safety and efficacy
    • Literature research
    • Manuscrips
    • Marketing applications in eCTD format (MAA, NDS, jNDA)
    • Orphan drug applications
    • Oharmacovigilance documents (risk management)
    • Development safety update reports (DSURs)
    • Periodic benefit-risk evaluation reports (PBRERs)
    • Periodic safety update reports (PSURs)
    • Plain language summaries
    • Posters
    • Pre...
      More Information » synterex.com/medical-writing

  • Clinical Science and Operations Services

    • Generate clinical content for publications, data review/safety meetings, decision-making task forces, and Agency/IRB communications
    • Provide medical monitoring support, including review of protocol deviations, line listings and medical coding, generation of queries, and hosting of regular medical monitoring meetings
    • Develop solutions (eg, team site, trackers) to enhance medical monitoring efficiency and oversight of both patients and CRO activities
    • Serve as site and CRO point of contact for protocol-related questions
    • Develop clinical content, including CDPs, CRFs, ICFs, and study manuals
    • Perform safety reviews and case processing
    • Undertake medical coding and deviations reviews
    • Provide site communications support

    More Information » synterex.com/clinical-science-and-operations

  • Regulatory Strategy and Planning Services

    Strategy and Planning: 

    • Kickoff meeting leadership (submissions and individual documents)
    • Meeting coordination
    • Coordinating document stakeholder input (eg, legal review)
    • Support for critical FDA communications/responses
    • Consulting for expedited approval pathways and designations
    • Regulatory CMC consulting
    • Consulting on clinical development plans
    • Interpretation of regulatory guidance and advising on disease- or topic-specific guidance
    • Preparation for regulatory interactions
    • Regulatory intelligence


    • Formatting Word documents
    • PDF rendering
    • Prepublishing (eg, bookmarking, linking)
    • Electronic submission through ESG and gateway configuration
    • eCTD viewer training and on-site support
    • Product family/metadata setup and lifecycle maintenance of serial submissions
    • Submission meeting leadership, includi...
      More Information » synterex.com/regulatory-strategy-and-planning

  • Quality Assurance and Quality Control Services

    • Manuscript evaluation (fitness for purpose)
    • Structural editing
    • Subject matter expert substantive line revisions
    • Verifying content accuracy and consistency
    • Copyediting
    • Proofreading
    • Formatting (eg, for electronic submission, for journal style)
    • Reference formatting/checking
    • Regulatory document audits
    • SOP development
    • Trial master file (TMF) audits
    • Training (eg, GCP, FDA regulations, GDP)
    • Inspection support
    • Editing tables, graphs, or figures
    • Fact checking
    • Data point verification
    • Writing/editing for ESL authors
    • Indexing
    • Style guide or program-level style sheet creation and maintenance
    • Compliance review (eg, SOPs, guidances)
    • Selection and customization of editing software and tools

    More Information » synterex.com/quality-assurance-and-quality-control

  • Information Technology Services and Collaboration Solutions


    • Customized collaboration suites for your use cases
    • Dedicated IT support for your submissions
    • Rapid response so you can meet your deadlines


    • VMware Partner
    • We are your solutions expert for mobility management and support
    • Mobile app development
    • Mobility migrations

    Office 365

    • Office 365 migrations
    • SharePoint development
    • Office 365 analysis and service delivery
    • Workflow design and support


    • Technology training for your whole team
    • Mobility training
    • Office 365 training
    • Miscellaneous training

    More Information » synterex.com/information-technology-services

  • Additional Services

    • Automation
    • Training
    • SOP writing
    • Redaction
    • Attendance at key governance meetings (eg, clinical subteam, CDP/TPP meetings) to communicate project status and coordinate client body of work and product messaging
    • Input on upstream activities (eg, tables/listings/figures, statistical analysis plans, reports, study milestones) to make the writing process seamless
    • On-site document finalization support
    • Implementation of best practices for documentation
    • Assistance with obtaining copyright clearance on reference via client subscription reference retrieval service
    • Document review system training and administration of work groups/access

    More Information » synterex.com/additional-services

Web Site: synterex.com 


  • Synterex
    122 Rosemary Rd
    Dedham, Massachusetts 02026
    United States
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  • Products6
  • Last UpdatedMay 23, 2023 11:33pm EDT


  • Alisa Lackey
    Alisa Lackey

    Business Operations Associate
    Dedham, Massachusetts

  • Jeanette Towles
    Jeanette Towles

    President and CEO
    Synterex, Inc
    Dedham, Massachusetts