We provide the most collaborative experts to work within your company - you'll never want them to leave!
Medical & Regulatory Advertising Promotional Review
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
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
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
MLR Review On Demand
Regulatory & Medical Just-in-Time Review
OSR’s MLR Review On-Demand service is here to give you the help you need, when you need it:
? Is your company in an early stage (Phase 2 or 3) and need review of a press release discussing clinical trial results or a materials for an upcoming scientific congress?
? Do you have a promotional piece(s) for an approved product that needs medical, regulatory, and/or legal review today (e.g., an expedited piece) and you're too busy to meet the commercial teams timelines or volume?
? Are you in Marketing and would like an additional opinion or benchmarking on a piece or a topic that's being considered by your PRC team?
? Are you in Regulatory, Medical or Legal and want to see if your comments or approach to a promotional piece/topic (e.g., CFL, Payer topic) are supported by your industry peers with extensive review experience?
OSR On-Demand Review in a few simple steps:
Step 1: You probably want to have us sign a CDA prior to discussing your project with OSR.
Step 2: Complete a brief explanation of piece(s), type of review required (Regulatory, Medical, Legal, or a combination), and date needed.
Step 3: OSR will send a Statement of Word (SOW) with a quote for your approval and signature*
Step 4: Upload your materials with references and the OSR expert reviewer will review the materials and be available to schedule a call, if needed.
*Pay invoice by credit card, check, or ACH transfer!
Recruit + Place + Support
Regulatory and Medical Review
Provide MLR Support for Business Continuity + We Recruit the Right MLR Resource + Place Them in Your Company
At OSR we know the difficulties in staffing your MLR review team with the right resource, in addition to ensuring the work gets done while trying to fill the position. OSR can help you meet business needs with expert interim support while we help you get the right candidate on board. Having sat in your chair, we understand how critical it is to find candidates with the right training, collaboration and professional experience for a successful MLR team. If your candidate has transferable skills but lacks the training or experience, OSR can be there for you with our Mentoring program as well.
Let us share our expert experience and the details of how the OSR Medical and Regulatory Review, Recruit + Place + Support program can help you succeed by supporting the critical MLR function while getting your new reviewer into the game.
Review Mentor Program
Reviewer Mentoring Program for Regulatory and Medical
At OSR, our team of reviewers have been working in advertising and promotion review - longer than we like to admit. We also perform countless advertising and promotion review process assessments for companies of all sizes, focusing on people, process and technology. Together, we provide our services to over 100 companies - and counting. OSR took all of this experience and developed the three part Reviewer Mentoring Program:
You select the right candidate. Or, we help you select the right candidate.
The OSR expert and your reviewer work together (Typical mentor program ranges from 6-12 months).
We hand off the review to your newly trained reviewer when they are ready.
Let us share our expert experience and get your new reviewers into the game!
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
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.
Compliance Program Development & Monitoring
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:
Perform program assessment
Identify and document inherent compliance risks
Compliance program development
Compliance monitoring and support
Report compliance concerns with OneSource Regulatory!
OSR has developed an efficient way for our clients to report compliance concerns. To take advantage of these services, contact OSR.
To report you concerns, visit www.Compliance-Reporting.com to get started!
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:
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