How do we help?
We are champions of the Promotional & Medical Review Process. Our Process Managers/Coordinators have facilitated the review & approval of over 400,000 assets for many of the leading companies in the industry. We are proficient in all major technology platforms. Our on-demand solution allows you to scale your business more efficiently and cost effectively.
Our primary role is to route assets through the review and approval process in accordance with your organizational processes and aligned with industry best practices. We partner with agencies, project owners and reviewers to ensure compliance, identify bottlenecks or process gaps, and maintain an efficient and expeditious process.
We understand that each organization has unique needs. Our Process Managers are highly trained on all aspects of content review, including annotation methods, meeting facilitation skills and workflow management, and work under the supervision of our highly experienced and knowledgeable management team. This scalable, customizable approach provides you with uniquely qualified resources who are experts in facilitating your specific process.
Our Process Management / Coordination team has facilitated the review of over 400,000 assets for many of the leading companies in the industry
Our Coordinator Services include:
Pre-review quality assessment, including development of submission quality checklists
Agenda creation, management and distribution
Document annotation and reconciliation
Document lifecycle management
Editorial review and proofreading
Document archival and expiry management
OPDP Submission Services
Timely and accurate regulatory submissions are the critical end goal of the review and approval process. Our Process Managers apply their expertise in metadata and technology platforms to compile a complete and accurate Form 2253 for regulatory signature. We partner closely with stakeholders, including internal regulatory submissions teams, to prepare filings for client submission.
Our Submission Services include:
Compiling digital file of asset, including related materials and references, if applicable
Preparing bookmarked CD’s
Preparing Form 2253 for regulatory signature
Compiling pre-clearance binders
Packaging and shipping submissions to OPDP
Reconciling DOFU and archival date in review platform
Significant increase in speed to market
Regain focus on departmental goals
Decrease operational costs across the enterprise
Increase content review speed and optimization
Increase scalability, efficiency and flexibility
Increase ROI – infrastructure and technology platforms
Transformation through Collaboration