Regulatory Strategy & CMC
OneSource Regulatory (OSR), is a specialized services firm that helps pharmaceutical companies successfully develop their regulatory strategy and develop Module 3 of the New Drug Application (NDA) and Biologics License Applications (BLA) for drug products and biologics respectively.
The OSR regulatory strategy staff can help you prepare for each regulatory milestone at each phase of development, including briefing package preparation, pre-Investigational New Drug Application (IND) preparation, and pre-NDA meeting preparation.
Our Chemistry, Manufacturing, and Controls (CMC) team members each have more than 25 years of regulatory experience, including formulation development, NDA/BLA CMC authoring, lab/manufacturing product and process development, and experience with biologics and small molecules. They also routinely interface with internal interdisciplinary teams (quality, clinical, operations) and health authorities. OSR supports activities from Phase 1 through post-approval.
What We Do
At OSR we use a proven approach. Our CMC team members have the formulation, drug development, and product marketing experience to:
- Prepare for health authority pre-filing meetings
- Provide expert strategy development advice and support
- Provide CMC writing capabilities to complete CMC sections
OSR services include:
Defined Processes to Complete Submissions
OSR staff can help you complete module 3 of the CMC section of your submission in accordance with FDA guidance provided by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and other health authorities. Our team has extensive experience writing CMC sections for U.S. and international regulatory submissions.
Flexible Staffing to Support Your Team
Get the right expertise and guidance when you need it.
Planning for Agency Meetings and Submissions
We can help you:
- Strategize regarding agency meeting requests and timing
- Prepare for meetings with agencies and manage feedback
- Prepare brief packages and dossiers that maximize CMC and quality information
Guidance for Manufacturing and Testing
Our team of experts can guide you through a number of processes, including:
- Transitioning from clinical to commercial manufacturing
- Identifying potential manufacturing and testing facilities for a drug substance/product
- Validating the commercial manufacturing process and identifying regulatory requirements
- Identifying stability data requirements
- Identifying requirements for U.S. versus ex-U.S. manufacturing
- Testing for global markets
- Developing analytical methods to meet validation requirements
Whether you are looking to support your team’s capabilities and capacity prior to hiring, you need expert help to fill a gap in your team’s experience, or you are anticipating peaks in workload, OneSource Regulatory welcomes the opportunity to learn more about your current and ongoing needs. We offer flexible expert consulting support models you can customize to your situation, with options for 10, 20, 30, or 40 hours per week.