SERVICES Standard Operating Procedure Development & Review

    The FDA Group provides expert SOP development and review services to help life sciences companies establish clear, compliant, and effective standard operating procedures. Our quality and regulatory specialists create SOPs that not only satisfy regulatory requirements but also serve as practical tools for consistent process execution and training. We develop documentation that clearly communicates critical procedures while maximizing efficiency and ensuring regulatory alignment.

    Contact us » Engagement models »

    We create procedures that drive compliance and consistency

    Well-crafted standard operating procedures are essential to maintaining regulatory compliance and operational consistency. Our approach to SOP development focuses on creating clear, concise documents that effectively communicate requirements while remaining practical for daily use. We understand the balance between regulatory compliance and operational efficiency, developing SOPs that satisfy both without unnecessary complexity.

    Our SOP development and review services services include, but are certainly not limited to:

    • New SOP Development

      Creation of compliant SOPs tailored to your specific processes and regulatory requirements.

    • SOP Review and Remediation

      Evaluation and updating of existing SOPs to ensure regulatory compliance and operational effectiveness.

    • SOP Harmonization

      Alignment of procedures across departments, sites, or following mergers/acquisitions.

    • Risk-Based SOP Development

       Creation of procedures using risk-based approaches to maximize effectiveness.

    • Training Material Development

      Development of corresponding training materials to support SOP implementation.

    • SOP Simplification

      Streamlining and optimizing complex procedures while maintaining compliance.

    • Electronic Document Management System Implementation

      Support for implementing and organizing SOPs within electronic systems.

    Contact us »

    Engagement Models

     

    Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

    ENGAGEMENT MODEL Consulting Projects

    Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

    Contact us » Learn more »

    ENGAGEMENT MODEL Staff Augmentation

    Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

    Contact us » Learn more »

    Engagement Model FTE Recruitment

    We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

    Contact us » Learn more »

    Why work with The FDA Group?

     
    • Exclusive life science focus and expertise
    • Dedicated account management team
    • Right resource, first time (95% success)
    • 97% client satisfaction
    • Total Quality Guarantee

    Read our brochure »

    Our Proven Process

    Introductory Conversation

    • About Us
    • About You
    • Scope Of Work

    Resources Definition

    • Background And Expertise
    • Location Of Resource
    • Rate Rightsizing

    Proprietary Resource Selection Process

    • In-House Subject Matter Experts
    • Recruiting Team External Search
    • Resource Identification

    Resource Presentation

    • CV And Rate
    • Perfect Match Summary
    • Interview Call Coordination

    Agreement Processing

    • MSA And Addendums
    • Supplier Qualification
    • Kickoff Coordination

    Account Management

    • Project Management Of Resource
    • Satisfaction Management For Client
    • Total Quality Guarantee

    Ready to enhance your procedural documentation? Contact us and get the conversation started.

    Contact The FDA Group today to discuss how our SOP development and review services can help you establish clear, compliant procedures. Our resources can be utilized to meet the wide range of quality assurance requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


    Fill out and submit the form below to share a few preliminary details and start the conversation. We pride ourselves on our responsiveness and will respond within one business day or less. We also take privacy as seriously as you do. All information is kept secure and confidential.