Regulatory Review Services
OSR currently provides medical, legal, and regulatory review services of promotional materials to over 50 biotech, nutrition, animal health, cosmetic, and pharmaceutical companies. We are not a staff augmentation or placement firm who simply drops a reviewer in your company — we are a specialized services firm with leadership experience. We hire the best, most experienced, and most collaborative experts in the industry and ensure that they have the latest resources and technological tools at their disposal. When a significant decision or question arises, you get the added value of a VP-level second opinion without additional expense.
What We Do
We help companies of all sizes with reviewers who understand the importance of compliance with policies, laws, FDA guidance, and industry codes. We will help your team achieve compliance and collaborate with you to deliver a powerful marketing message or disease awareness campaign. We pride ourselves on being solution-oriented and utilizing our in-depth experience with digital advertising and promotion.
Regulatory Review of Advertising and Promotions
ACCESS SUPERIOR REVIEW RESOURCES
Whether you are a small, mid-sized, or large company, OSR can provide you with the help you need for an effective launch and we can also help facilitate a successful legacy or brand transitioning. Our employees are the best of the best in the industry, with the in-depth experience in regulatory affairs you look for in a consulting company.
WORK WITH AN EXPERT PANEL
Get the answers you need from our panel of regulatory experts — we’re here to assist with all complex promotional issues.
Medical Review of Promotional Materials
GET THE HELP YOU NEED
OSR provides cost-effective resources to handle day-to-day review responsibilities in medical affairs, without sacrificing medical accuracy or integrity.
GRANT REVIEW EXPERIENCE
OSR participates in the review of medical educational grants to help companies ensure they maintain the necessary compliance with guidelines.
BETTER, MORE COST-EFFECTIVE SERVICES
OSR provides legal reviewers who understand the risks associated with promotional activities. Our services are also available at a lower hourly rate than many law firms charge, and you will still work with experienced, knowledgeable reviewers.
Materials We Can Review
Our review services are available at any stage of the process – pre-approval, launch, post-approval brand support, or whenever you need us – and we are able to review a variety of materials. From prescription and OTC products for both humans and animals to dietary supplements and medical devices, we have the expertise to help your company succeed. The following list contains a sample of the material types we have reviewed before and the services we have offered:
• Disease awareness campaigns — we offer input and review
• Congressional activities — we review company-directed activities and offer guidance
• Managed care communications — we offer review services and provide guidance
• Press/Public affairs activities
• Press releases — we can help with Phase III data, milestone events, NDA filing, and more
• Concept reviews for branded product campaigns — for healthcare providers, consumers, and managed care
• Digital promotional materials
• Social media content — our work includes posts and responses
• Health care provider materials
• Managed care materials such as FDAMA 114
• Sales training materials
• Direct-to-consumer advertising — our services address print, radio, TV, online and other visual mediums
• Scientific publications
• Advisory boards
• Speaker training programs
• Medical education for both physicians and patients
• Grant programs
• MSL materials
• OPDP or APLB product advisory comment submissions – our services include authoring, editing, and preparation
• Promotional materials — we offer regulatory oversight of production, including for film and video
• Ongoing internal committee work assignments, including medical reviews, scientific publications, educational grants, charitable contributions, and more
We offer a variety of support models to meet the needs of your company. Our flexible expert consulting is available during peak review periods, when a staff member is on leave, a headcount is not available, or when you require full or partial outsourcing. We also offer on-demand review resources with options for 10, 20, 30, or 40 hours per week.
PROMOTIONAL PROCESS DESIGN & IMPROVEMENT Services Available with OSR:
OneSource Regulatory also helps clients design or improve processes for the production, evaluation, and approval of promotional materials. An ineffective or nonexistent review process can become a major problem for your company. We help you get it right with an established, optimized approach.
Create a Review Process
We will help you design and implement an efficient promotion and advertising process that will be scalable to your organization’s needs, skills, and size.
Improve Your Review Process
If you need to optimize your current review process, we will provide recommendations on how to improve the people, process, or technology of your existing program. We will also provide an integrated change, communications, and training plan to help you implement any desired changes.
Whichever service you choose, OneSource Regulatory will also provide the backstop policies, procedures, and step-by-step work instructions that will help you turn an idea into reality. We will also ensure that the results are compliant with internal controls, external regulations, and statutes. Most importantly, we will ensure that the new program contains the right processes and procedures for your organization and culture.