Our firm delivers services within our core capabilities to ensure compliance in the Medical Device, Pharmaceutical, and Biotech Industries.
Our Services
Quality
Quality Processes and Quality Systems are the backbone of any Life Sciences Company’s ability to manage their products’ safety and performance.
Our quality services span 21 CFR 210, 211, 820 (domestically) and other international standards such as ICH’s Q series and ISO 13485 and 14971.
Whether you need help improving the quality within your supply chain, completing failure investigations, managing CAPAs, or an entire quality system remediation or implementation, GxPartners can help with all of your quality needs.
QMS
Quality Engineering
Supplier Quality
Risk Management
CAPA
Complaint Handling
NCR
Design Controls
Document Controls
Batch Records/DMR/DHR
Regulatory
Regulatory Affairs and Regulatory Compliance is the key to getting your products on the market and keeping them there.
Our Regulatory Affairs experience includes helping with pre-market activities, post-market surveillance activities, and in the event of a field failure, we can help with recall support.
Our Regulatory Compliance services can provide valuable third-party audits and assessments that ensure you don’t get caught off guard when regulators pay you a visit.
Audits and Assessments
483/Warning Letter Remediation
Premarket Submissions
510k/PMA/NDA/ANDA/BLAGxP Compliance
Technical Files/DHF
Post Market Surveillance/MDR
Recall Support
Validation
Risk-based Validation is critical for any Life Sciences manufacturer in order to demonstrate that their products and processes consistently perform as intended.
We can help you provide the objective evidence required to prove that your production processes and systems produce a reliable product with every batch or lot produced.
We can implement a program from the ground up to handle all of your Commissioning, Qualification, and Validation (CQV) needs, validate your specialized processes, validate complex software or automated systems, perform facility, utility, or equipment C&Q, or validate a spreadsheet. No validation job is too big or too small.
Process Validation
Equipment Qualification
Software and Computer System Validation
Automated Equipment Qualification
Test Method Validation
Cleaning Validation
Commissioning and Qualification of Facilities, Utilities and Equipment
Validation Master Plans (VMP)
Validation Programs