Even to experienced companies, Cord Blood Regulation and Guidance can be confusing and unclear. Reglera’s Cord Blood Compliance Services are specifically designed to provide everything your company needs to ensure sustained compliance and to legally market your cord blood products in the United States. Reglera’s extensive experience in the HCT/P market and in sucessfully preparing pre-market applications to FDA provides our clients with expertise necessary to be successful in this complicated regulatory environment.
Whether you need to prepare a premarket submission (BLA / IND), are looking to develop a quality system in compliance with applicable parts of 21 CFR 1271, 200, 600, or need an assessment of the work you have already performed, Reglera is the most experienced, qualified partner you can choose.
Primary Services
Reglera offers comprehensive services in each of the following areas:
Premarket Submissions
- Route-to-Market Strategy Development and Planning
- Early collaboration with FDA on Labeling Development
- Test Planning
- BLA Preparation
- IND Preparation
- FDA Submission Correspondent
Quality System Development and Execution
- Development and Implementation of complete Quality Systems compliance with 21 CFR Parts 1271, 210, 211, 600 and 610
- Key Quality System Outsourcing Activities (via electronic web-based solutions); Document and Change Control, Training Records Management, Donor Eligibility, Complaint Handling, Internal Audits, Supplier Quality Assurance and Adverse Experience Reporting
- Process Validation (collection and processing); Protocol Development, Execution, Data Analysis and Report Writing
- Establishment of Environmental Control and Monitoring Programs
- Other Validation Projects: Container Closure Systems, Packaging / Shipping, Analytical Methods, Test Methods, Software / Computer Systems, Sterilization, Water Systems, HVAC, Cleaning
Audits and Assessements
- Regulatory Gap Assessments; Evaluation of compliance with specific regulatory requirements and guidance
- Regulatory Mock Inspections; Inspections conducted in a similar manner to regulatory bodies for the purpose of educating team members on how to appropriately prepare and manage a regulatory audit
- Pre-Licensure Inspection Preparation Audit; Audits conducted to help clients prepare for a pre-licensure inspection
- Specific Targeted Assessments; Evaluation of a particular area with the intention to identify any potential weakness and provide guidance on appropriate remedial action
Why Choose Reglera
If the right regulatory partner for your company is one that not only advises, but specializes in implementation and results, choose Reglera. Our combination of specific tissue and blood experience and proven results with FDA premarket submissions will accelerate your products to the market and ensure compliance and operational efficiency.
