GVI Clinical Development Solutions
GVI CDS is a consulting company providing comprehensive services in clinical development, regulatory affairs, quality assurance, project management, scientific writing, and pharmacovigilance for pharmaceutical, biotechnology, and medical device companies. Their mission is to accelerate product development and ensure safety and integrity in medical product development, helping clients bring their products to market efficiently and cost-effectively.
Industries
Nr. of Employees
small (1-50)
GVI Clinical Development Solutions
Products
Medicinal chemistry and custom synthesis services
Medicinal chemistry, custom organic synthesis (milligram to multi-kilogram scale) and analytical chemistry services offered via an affiliated laboratory to support early drug discovery and compound supply.
ISO 13485 Certification Service
Certification service for ISO 13485, a globally accepted standard for quality management systems in medical device development and production, required by Health Canada and FDA.
ISO 14155 Certification Service
Certification service for ISO 14155, the standard providing guidelines for clinical investigations involving medical devices in human subjects following Good Clinical Practice (GCP).
ISO 14971 Certification Service
Certification service for ISO 14971, the standard used for medical devices including software as a medical device (SaMD) and in vitro medical devices throughout their lifecycle.
ISO 9001 Certification Service
Certification service for ISO 9001, an internationally recognized standard for quality management across various industries to enhance performance and fulfill customer needs.
CDS Pharmacovigilance Services
Complete pharmacovigilance services in Canada and the US during clinical trials and post-market approval, supported by a validated Clinical Safety Database based on E2B and MedDRA standards.
Medicinal chemistry and custom synthesis services
Medicinal chemistry, custom organic synthesis (milligram to multi-kilogram scale) and analytical chemistry services offered via an affiliated laboratory to support early drug discovery and compound supply.
ISO 13485 Certification Service
Certification service for ISO 13485, a globally accepted standard for quality management systems in medical device development and production, required by Health Canada and FDA.
ISO 14155 Certification Service
Certification service for ISO 14155, the standard providing guidelines for clinical investigations involving medical devices in human subjects following Good Clinical Practice (GCP).
ISO 14971 Certification Service
Certification service for ISO 14971, the standard used for medical devices including software as a medical device (SaMD) and in vitro medical devices throughout their lifecycle.
ISO 9001 Certification Service
Certification service for ISO 9001, an internationally recognized standard for quality management across various industries to enhance performance and fulfill customer needs.
CDS Pharmacovigilance Services
Complete pharmacovigilance services in Canada and the US during clinical trials and post-market approval, supported by a validated Clinical Safety Database based on E2B and MedDRA standards.
Services
Program and study-level project management including planning, budgeting, resource allocation, vendor oversight and timeline management for clinical development programs.
End-to-end clinical trial services including protocol development, site selection and monitoring, investigator contracting, feasibility assessments and clinical vendor management.
Regulatory planning and submission support including strategy development, preparation of submission dossiers, and interaction planning with health authorities.
Medical needs assessment, indication prioritization, development planning, target product profile definition, and business planning including partner and investor presentation support.
End-to-end pharmacovigilance services including validated safety database implementation, AE/ADR management and coding, periodic safety report preparation, signal detection and REMS support.
Preparation of regulatory and scientific documents across development stages, including protocols, clinical study reports, investigator brochures, informed consent forms, and publications.
Program and study-level project management including planning, budgeting, resource allocation, vendor oversight and timeline management for clinical development programs.
End-to-end clinical trial services including protocol development, site selection and monitoring, investigator contracting, feasibility assessments and clinical vendor management.
Regulatory planning and submission support including strategy development, preparation of submission dossiers, and interaction planning with health authorities.
Medical needs assessment, indication prioritization, development planning, target product profile definition, and business planning including partner and investor presentation support.
End-to-end pharmacovigilance services including validated safety database implementation, AE/ADR management and coding, periodic safety report preparation, signal detection and REMS support.
Preparation of regulatory and scientific documents across development stages, including protocols, clinical study reports, investigator brochures, informed consent forms, and publications.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Quality assurance and GMP compliance
- Pharmacovigilance and safety reporting
Key Technologies
- E2B pharmacovigilance standard
- MedDRA coding
- eCTD formatted regulatory documents
- ICH-GCP