G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research, Quality Assurance and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of 2,500 consultants in over 100 countries, we can find the right professional, at the right level, in the right location to fulfill your staffing needs. Building a cohesive team that can meet aggressive deadlines is a daily challenge in the industry. With our highly experienced, multi-disciplinary background, we ensure your team is always at full strength and operating at maximum capacity. All our consultants are experienced in the use of multiple systems to speed up the onboarding process. Hand-picked by our in-house experts with your specific project in mind, they are continually overseen by us to ensure they’re exceeding your expectations. Whether you need an individual or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings to your resource budget, and allows you to flex your headcount in line with operational demands.
• Audits of Trial Master Files, Clinical/Investigator Sites, CROs
• Establishment of quality system relating to Clinical Operations / Clinical Quality Assurance
• On-site/remote QA services
• Review of protocols, informed consent forms, investigator brochure, clinical study reports
• Release of investigational product for clinical studies
• Monitoring of clinical study sites
• GCP training
• Preparation/assistance with regulatory authorities’ inspections
Our native English writers and local language writers are experienced across a wide range of medical and scientific subjects, multiple therapy areas and product types
Clinical Documents: Investigator Brochures, Protocols/ICs, Clinical Study Reports, Clinical Expert Reports
All Modules of the Application Dossier: Administrative, Quality, Non-Clinical, Clinical
The pressure on businesses to ensure CMC Regulatory Compliance has never been higher, in terms of potential penalties, litigation and impact on brand perception.
G&L supports compliance efforts by:
– Reviewing your License against manufacturing processes and practices
– Conducting Gap Analyses to highlight non-compliance issues
– Putting a Remediation Plan in place
– Preparing Variations and submitting to relevant Agency
Access to current, validated and first-hand Regulatory Intelligence has never been so important, in order to successfully navigate approval pathways in new markets.
Over the past 10 years, Outsourcing has become a hot topic within Regulatory Affairs: everyone is doing it. But is it right for your business, and what should you outsource?
G&L will give you the very best advice by:
– listening to what you say, to gain a deep understanding of your business
– strategizing on how to achieve your goals through working with external agencies
– working in genuine partnership with you for as long as you need us
The effective application of scientific, product-specific and local knowledge is at the foundation of a successfully-executed Regulatory Strategy.
Regulatory Strategy specific to product type and approval market
Our experts will work closely with you to understand and achieve your goals:
Strategic Outsourcing & Development Offering
Scalable, dedicated teams focused on creating long-term partnerships with Clients
– All levels of experience with specific skill set
– Measurable results
Carefully-considered, well-written and comprehensive submission packages are a central factor in achieving regulatory approvals in a timely manner
The License Holder is legally responsible for making sure their License is properly maintained, and the product is strictly manufactured to approved terms
G&L has extensive experience in conducting License Maintenance activities across the world, with many different Health Agencies and all product types:
– Putting License Maintenance processes in place before Marketing Authorization is granted to minimize risk of future compliance issues
– Post-approval activities, including preparation and submission of Variations, Renewals, Line Extensions and Safety Updates
Our early and late phase Clinical Scientists are medically and/or Ph.D qualified. They provide:
– Scientific consultancy for individual protocols or complete clinical development programs
Clinical Medical Writing
Experience across all kinds of medical writing and therapy areas: Manuscripts, Clinical Documents, Investigator Brochures, Journals
Native English writers
Local language writers
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