OSR provides medical and regulatory review services with our experienced staff that are overseen and mentored by leaders who have sat in your chair:

• • • • Service provider in over 100 companies of all shapes and sizes

      • Experience in pharmaceutical, biotechnology, medical device (Class I, II, III), nutritional supplements, animal health and cosmetic products

      • Collaborative professionals who launch new products (pre-approval, launch and post-approval brand support), maintain growth and legacy products

        • Promotional Materials - HCP, Consumer and Managed Care

        • Press/Public Affairs Materials and Activities

        • Medical Affairs/R&D Materials

MEDICAL REVIEW

Cost-effective resources to manage day-to-day review responsibilities, without sacrificing scientific accuracy or integrity.

· Promotional and Medical Review Committee participation

· Medical accuracy and evidentiary standard review (substantial evidence, competent and reliable/FTC)

· Broad therapeutic experience

REGULATORY REVIEW

Experienced and collaborative regulatory professionals

· OPDP or APLB product advisory comment submissions –authoring, editing, and preparation

· Successful interactions with OPDP

· Guide teams through FDA regulations, guidance documents and enforcement communications

· Deep understanding of trial design and outcomes

The OneSource Regulatory™ team includes experienced staff to help companies develop HCP and consumer labeling for prescription drugs and biologics.

OneSource Regulatory™ provides strategic support to your team. Our experienced staff can manage the entire product labeling process, including development of:

• • • Company Core Data Sheets (CCDS)

    • U.S. package inserts

    • Medication guides

    • E.U. Summary of Product Characteristics (SPC)

    • Patient Information Leaflets (PIL)

Develop labeling content, manage and support complex labeling and regulatory situations, manage health authority communications, and assist in the design of your company’s labeling policy and process - that's what we do at OSR.

OneSource Regulatory™ helps companies develop and maintain effective compliance programs.

Monitoring and Auditing Support

The compliance monitoring program at OneSource Regulatory includes:

• • • Field monitoring: ride-alongs, speaker programs and other events

    • Monitoring of data analytics from sales representatives, HCP interactions, and email

    • Strategic monitoring plans such as quick start guides and plans for protocol development

Compliance Program Development

OneSource Regulatory™ helps small companies develop ethics and compliance programs using the Office of the Inspector General’s seven elements of an effective compliance program as a starting point and then develop programs to meet state and federal compliance requirements to avoid unwanted scrutiny, enforcement, and fines. To make that happen, we implement our proprietary four-step process:

• • • 1. Perform program assessment

      2. Identify and document inherent compliance risks

      3. Compliance program development

      4. Compliance monitoring and support

OneSource Regulatory™ helps companies implement the correct solutions of processes, standards, systems, templates, and best practices for effective Regulatory Operations.

With the right Regulatory Operations group, you can achieve high quality document management, data management, and regulatory agency submissions.

OneSource Regulatory™ provides strategic support to your team. Our experienced staff can assist with:

• • • Process Optimization

    • System Implementations

      • • Document Management

        • Submission Management

        • Publishing

        • Archiving

        • RIM

    • Submission Managers

    • Publishers

    • Fully Outsourced Regulatory Operations

Promotional Material Review Process & Marketing Materials Management

• Commercial Operations Infrastructure Build & Support (Policy, Process, and Procedure Development)

• Promotional Material “Medical, Legal, Regulatory (MLR)” Review Process Management

• Technical System Implementation (Veeva/PromoMats)

• Marketing Materials Execution Project Management (Print & Digital Production and Distribution)

• HCP & Patient Speaker Bureau and Speaker Program Operations Management

• Medical Conventions, Exhibits, Meetings & Events Management

• Vendor/External Partner Procurement & Management