Outsourced Regulatory And Medical Review
Resources Customized to Your Needs
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.
Work with an Expert Panel
Assemble a unique panel of our experts to assist your organization on complex promotional issues that may arise.
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.