Combination Products
Combination Products
We understand the intricacies of drug/device interactions and how to navigate the regulatory landscape and create successful documentation for the Combination product development whether it’s a pre-filled syringe or auto injector.
Case Studies:
Combination Product development of System and sub-system requirements and analysis of interactions and risk assessment of drug-device interfaces
- Creation of a comprehensive FMEA of Use, Design, and Process including risk mitigations to support the Risk Management Report for multiple combination products such as Pre-Filled Syringes and On-body injectors
- Development of system and sub-system requirements based on ISO standards for different combination products such as on-body injector
Post-Market Design Changes for a Pharmaceutical Company
- Coordination of change packages for Design changes including updates to Design inputs and assessment of Design verification activities for Combination products.
- Conducted Design Reviews for design changes for combination products in compliance with 21 CFR part 4.
Combination Product Development to assess risk with respect to severity of harm to the patient per ISO 14971:2019
- Residual risk evaluation through Benefit-Risk Analysis and establishment of criteria for which residual risks are communicated to the end user
- Reporting device failures and aligning between Problem codes and Adverse Events
Quality Systems
- Quality Systems Management
- CAPA / Root cause Analysis
- Product Complaint Handling
- Trending
- Post-Market Surveillance
- Quality Plan
- Field Actions
- Nonconformance management
Research & Development
- Combination Product Development
- Design Engineering
- Mechanical Engineering
- Electrical Engineering
- Product development
- Systems Engineering
- Risk Management
Manufacturing
- Test Method Validation
- Process Validation
- Equipment Validation
- Utility System Validation
- Cleaning Validation
- Validation Master Plans
- Computer System Validation
Compliance Management
- Consent Decree / Warning Letter Remediation
- Design History File Remediation
- Quality System Audits
- Audit Responses
- Technical File/DD/MDR/ Remediation