Regulatory Operations
How are we different from other regulatory operations firms?
We use a cross-functional "eyes on - hands-on" approach. The same senior-level regulatory scientists who strategize, also author and review every document we produce. This approach harmonizes your strategy and enhances the knowledge of knowing when and how to interact, with a global perspective in mind.
We write, review and/or submit.
We plan, formulate questions, write, review, and/or submit.
Regulatory Strategy & Drug Development
We help clients unlock value by engaging effectively with regulators.
As you seek investment, we create strategic drug development and regulatory plans that support your conversations and align milestones.
Based on client objectives, we help prioritize, define and accomplish regulatory milestones by offering strategic and full operational support. We impress upon our clients how working collaboratively with regulators will allow for organization and preparation for nonclinical, clinical and regulatory strategy.
We maneuver products through the regulatory framework, piloting the program into a position that is poised to accelerate into marketing as early as possible. Your success is our success and we go to work for it.
Deliverables Include
- Preparation and representation for EMA and FDA engagement
- ODD Feasibility Assessments
- Feasibility Assessments for expedited program applications
- Strategic Review of applications
- EMA/FDA Regulatory Positioning
- Nonclinical Development support
- CMC review and support (including IMPD and Module 3)
- Epidemiology Forecasts
- State-of-art Benchmark Analysis
Our team combined, possess comprehensive knowledge of orphan drug development and a wealth of regulatory strategy from the hundreds of global agency interactions and work on successful orphan programs. Our sole focus in orphan drugs maintains our resourceful mindset and requires us to always consider novel strategies..
Medical Writing
Medical Writers compile, write, and edit deliverables covering all phases of research for submission to regulatory agencies.
A key task of the Medical Writer is to be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents the team prepares must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and often a company or client template.
This combined with comprehensive literature searches to enhance and provide background are delivered with all RareMoon's deliverables.
We write, review, and QC.
To accomplish the primary goal of communicating information in clear, concise and compliant writing, medical writers perform many tasks.
eCTD Submissions & Publishing
RareMoon is well equipped with the expertise to create any XML file for submission to FDA, EMA and other regulatory authorities.
Of note, the FDA has officially transitioned to XML based files for specific information including INDs & IND Amendments. The EMA is also implementing and improving ways to apply for designations, and interact with the various committees within the Agency.
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