Protocol Design for Biologics
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In this episode of RCA Radio, host Brandon Miller, Steve Lynn, Regulatory Compliance Associates Inc.’s (RCA) Executive VP of Pharmaceuticals, and Walter Mason, RCA’s Sr. Director of Quality Control and Consulting Services go over protocol design for biologics, the importance of keeping data, and the different methods of analyzing protocol design data.
About RCA’s Biotech Consulting
Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics services include:
Regulatory Affairs
Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.
- Preclinical & CMC Consulting
- FDA Meetings & Briefing Package Assistance
- Clinical Trial Applications
- Marketing Applications
- Medical Writing
- Lifecycle Management
- Submission Planning & Strategic Support
- eCTD Publishing & Submissions
- Strategic Consulting & Intelligence
- US Agent
- Project Management Support
- Clinical Development Support
- Clinical Research Organization (CRO) Sourcing
- Analytical Development Support
- Bioassay Design & Validation
- Immunoassay Support
- Statistical Analysis & Specification Setting
Compliance Assurance
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.
- Assessments
- Current Good Manufacturing Practice (cGMP)
- Corrective & Preventive Action (CAPA), Investigations & Deviations
- Facility & Maintenance
- Data Integrity
- Quality System Gap Assessment
- Audits
- Supplier Audits
- CRO Audits
- cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
- cGLP Audits
- Good Clinical Practices
- Preparation, Training & Inspection Readiness
- cGMP Fundamentals (Annual Training Required by Regulations)
- Quality System Regulation
- Risk Management
- Investigations, Deviations & CAPA & Root Cause Analysis
- Validation & Technology Transfer
- Purchasing Controls & Supplier Management
- Document Management & Change Control
- Audit Readiness
- Quality Culture & Management Responsibility
- Data Integrity & Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
Quality Assurance
Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have experience spanning major corporations and start-ups.
We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
- Quality Management System Implementation
- SOP Development
- Document Control Systems
- Change Control
- Laboratory Operations & Control
Remediation Strategy & Response
Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation.
With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
- Regulatory Action
- 483 Response & Remediation
- Warning Letter Response & Remediation
- Consent Decree Response & Remediation
- Oversight Services
- Consulting
- Comprehensive Audits
- Remediation Plan Development & Implementation
- Manufacturing Support
- Re-validation of Existing Equipment & Processes
- Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility
- Facility Improvements (Aging Facilities)
Strategic Consulting
Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates® Inc.’s worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.
- Portfolio Management
- Mergers & Acquisitions / Due Diligence
- Staffing Support
About RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
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