Services
DGC is a trusted partner in the biopharmaceutical industry. With a deep expertise spanning over three decades, we specialize in providing comprehensive services designed to ensure the highest standards of Quality and Compliance. Our offerings include Quality Assurance, Regulatory Compliance, Chemistry, Manufacturing, and Controls Support, and other GXP Services.
From developing QA strategy and Quality Systems to vendor qualification and batch disposition to providing regulatory, CMC and clinical trial support, DGC is committed to delivering solutions that enhance safety, integrity, and efficiency. Whether you need assistance with document control, laboratory setup, or compliance with FDA and EU regulations, our experienced team is here to support your success every step of the way.
Explore our range of services and discover how DGC can help your organization achieve its goals.DGC provides Quality Assurance, GXP Compliance and other consulting services to virtual and fully integrated biotechnology/ pharmaceutical/ device companies for all phases of product development, preclinical through commercialization.
Focus areas
Quality Assurance
- Quality Agreements
- Batch Record Review and Product Release
- Document Control
- Laboratory set up
- Validation: Process/Utility/Equipment/Analytical
- IND/NDA data integrity
- Stability and Validation Programs Development
- Equipment Qualification Protocols/Reports
Regulatory Compliance
- QA Strategy and Support
- GMP Compliance
- Quality Systems Development
- PAI support – FDA interaction training, data integrity, auditing, data QC
- EU requirements / QP support and interactions
- Auditing
- Training: development and presentation
CMC Support
- CMC Project Management
- CTM Supply Chain Logistics
- CMC Support
- Analytical / QC
- Contract Manufacturing Liaison
- IND/IMPD CMC section preparations
GXP Services
- GLP compliance
- Project management
- Drug Safety
- GCP compliance
- Clinical Operations/ Clinical Trial Monitoring
- Med/Tech writing