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Outsourced Regulatory And Medical Review

Resources Customized to Your Needs

Our primary focus is on providing expertise in the areas of Regulatory and Medical Advertising/Promotion Review,  the development of Regulatory Drug Product Labeling, and Commercial Compliance.  We provide expert resources selected by people who have actually held the job inside pharma companies.


Augment Current Staff

Whether you are a mid-size or large corporation, OneSource can help you augment and expand your current staff to manage upcoming changes.


Full Outsourcing Capabilities

Keep the agility of a small company environment, while taking advantage of the benefits of deep expertise and comprehensive knowledge.

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Work with an Expert Panel

Assemble a unique panel of our experts to assist your organization on complex promotional issues that may arise.

Promotion & Advertising Review

OneSource Regulatory employs the top experts in the field.  Our experts will help ensure that your promotional programs and materials are fully compliant with your own internal policies and procedures, as well as applicable federal agency rules (OPDP (DDMAC) and CDRH), state regulations and industry standards (PhRMA and AdvaMed Codes).  We have experience in all types of programs:

  • Prescription (Rx) drug products (human and animal drugs)
  • OTC products (human and animal drugs)
  • Medical devices
  • Digital and social media promotional materials (online, online TV, web)
  • Health Care Provider materials
  • Managed care materials (FDAMA 114)
  • Sales and Marketing Material reviews
  • Direct to Consumer Advertising (print, radio, TV, online and other visual media)
  • Scientific publications
  • Advisory Boards
  • Speaker Training Programs
  • Medical Education (Physicians and Patients)
  • Grants Programs
  • Social Media content (including posts and responses)


  • Authoring, editing and preparation of routine new product advisory comment submissions to OPDP.
  • Regulatory oversight of promotional materials production, including film and video production.
  • Participation in ongoing internal committee work assignments – Medical Review, Scientific Publications, Educational Grants, Charitable Contributions, etc.


Medical Review

Providing Superior Accuracy & Freeing Up Medical Affairs Resources

Medical Affairs staff members are seeing increased responsibilities with decreasing resources.  OneSource is your partner that can provide cost effective resources to handle those day-to-day responsibilities.  Our experts have deep experience and knowledge in the industry.

What this means for you:
Your resources are freed up to work on driving growth for the company, without sacrificing an ounce of medical accuracy.

Examples of medical review work completed:

  • Full medical review of all promotional and educational materials.
  • Pre-Launch, launch and Medical information booth review.
  • Medical oversight of promotional materials production, including film and video production.
  • Developing and running a Grant Review Committee.
  • Participation in ongoing internal committee work assignments–Medical Affairs, Scientific Publications, Educational Grants, Charitable Contributions, etc.



Promotional Process Design / Process Improvement

OneSource Regulatory helps our clients to design and implement or improve processes that govern the production, evaluation and approval of promotional programs/materials.  We first conduct a technical and operational process needs assessment and then:

  • If you need a process – Help you design and implement a promotion and advertising process that will be efficient and scalable to your organization’s needs, skills and size.
  • If you need an improved process – We will provide recommendations on how to improve the people, process or technology elements of your existing program, along with an integrated change, communications and training plan to achieve the desired changes.
  • In either case, we will also provide the backstop policies, procedures and step-by-step work instructions that turn an idea into reality.  And we will ensure that the results are compliant with needed internal controls and external regulations and statutes, but most important, are the right processes and procedures for your organization and culture.

Expert Advisors at Your Fingertips

Comprehensive assistance for short-term projects or long-term needs.

+1 833-OSR-TEAM