Why OSR?

OneSource Regulatory (OSR), is a specialized services firm that helps pharmaceutical companies successfully develop their regulatory strategy and develop Module 3 of the NDA and BLA for drug products and biologics respectively.

OSR Regulatory strategy staff helps you prepare for each regulatory milestone at each phase of development, including briefing package preparation, pre-IND and pre-NDA meeting preparation.

Our CMC team members each have over 25 years of experience in formulation development; NDA/BLA CMC authoring; lab, manufacturing, product and process development; biologics and small molecules; and routinely interface with internal interdisciplinary teams (quality, clinical, operations) and health authorities. OSR supports activities from Phase 1 through post-approval.

What We Do

At OSR we use a proven approach – our CMC team members have over 25 years of formulation, drug development and product marketing experience to:

  • prepare for health authority pre-filing meetings
  • provide expert strategy
  • provide CMC writing capabilities to complete CMC sections

OSR services include:

  • Defined Processes to Complete Module 3 of the CMC section of your submission

    • In accordance with FDA Guidance provided by CDER, CBER and other health authorities
    • Writing CMC sections for US and international regulatory submissions

  • Flexible Staffing Resource to Support Your Team

    • Expertise and guidance when you need it
  • Planning for Agency Meetings & Submissions

    • Strategies regarding agency meeting requests and timing
    • Preparing for meetings with agencies and managing feedback
    • Preparing brief packages and dossiers that maximizes CMC and quality information

  • Guidance for Manufacturing & Testing

    • Transitioning from clinical to commercial manufacturing
    • Identifying potential manufacturing and testing facilities for drug substance/product
    • Validating the commercial manufacturing process and identifying regulatory requirements
    • Identifying stability data requirements
    • Identifying requirements for US versus ex-US manufacturing
    • Testing for global markets
    • Analytical methods validation requirements

 

Support Models

Whether you are looking to support your team’s capabilities and capacity prior to hiring, need expert help to fill a gap in your team’s experience, or are anticipating peaks in workload, we welcome the opportunity to learn more about your current and ongoing needs. We offer the following support models:

  • Flexible Expert Consulting and Hours
    • 10, 20, 30 or 40 hour per week options
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