Consulting Services
CMC Regulatory and Quality Consulting
Regulatory and Quality requirements are equally important and are dependent on each other to run your organization as smoothly and effectively as possible. Our consultants have broad experience in CMC, Regulatory Affairs and Quality and can help you navigate the regulatory and guidance requirements for your product. Our consulting model isn't just to offer an option, we will work with your team to define a path that meets your milestones and partner with you to provide the resources required to meet those goals.
External Consultant Services
- Global CMC Strategy recommendations
- Consulting on CMC Regulatory Submissions (author or review)
- CTD Modules 2.3 and 3 for IND, CTA, IMPD, BLA and MAA
- Pre-IND and End-of-Phase Agency meeting requests and briefing document preparation
- Gap Analysis of Clinical Trial Phase readiness
- Tracking and Risk mitigation of Agency commitments
- Gap Analysis of GMP Quality Systems - Navigating Phase appropriate readiness
Post-Gap Analysis Strategy Execution
We provide action items to correct the deficiencies and outline a step-wise plan from gap analysis to implementation. We work with your team and develop systems that work for your product, facility and staff. Quality system development is tailored to fit your needs and developed in conjunction with your team
Quality System Development
- Program development for Deviations, OOS, CAPA and Change Control systems
- Risk Assessment
- Environmental Monitoring (EM) Gap Analysis and Excursion Reports
- Analytical method development and validation strategy
- Development, assessment and evaluation of Stability Program
- Development and gap assessment of Raw Material Program (including vendor audits)
- Development of Change Control and Risk Assessment systems
Staff Training
At QOS Bio, quality system development means we train your staff on any quality system that is developed for your organization, in addition to offering Annual GMP Training.