Operating Models
Maximize the scalability, cost-effectiveness and efficiency of your function, project or organization through a strategic outsourcing partnership with G&L
Operating Models
Maximize the scalability, cost-effectiveness and efficiency of your function, project or organization through a strategic outsourcing partnership with G&L
Full Service Outsourcing (FSO)
Partner with G&L to outsource your entire regulatory or quality function.
End-to-End Accountability
A complete suite of services, across the entire product lifecycle.
Cost Efficiency
Eliminates the need for maintaining an in-house regulatory team, reducing overhead costs like salaries, training, and infrastructure. Strategically leverages low-cost centers of expertise.
Operational Efficiency
Optimize processes and leverage economies of scale, by utilizing G&L’s proprietary continuous improvement methodology.
Scalability & Flexibility
Deliver easier-to-scale operations in line with your evolving business needs. Long-term partnership that ensures continuous improvement, innovation, and proactive risk management.
Specialized Expertise
Extensive experience across multiple regulatory frameworks (FDA, EMA, MHRA, etc.), ensuring compliance in all target markets. Access to a global network of regulatory professionals helps with faster approvals and market entry.
Seamless integration and Reduced Management Effort
Reduction of management complexity by handling all regulatory activities under one provider. Frees up internal leadership to focus on core business strategy.
Functional Service Provider (FSP)
Partner with G&L to manage specific functions or services, rather than outsourcing entire projects or processes.
Scalability & Flexibility
Deliver easier-to-scale operations in line with your evolving business needs. Long-term partnership that ensures continuous improvement, innovation, and proactive risk management.
Cost Efficiency
Optimize budgets by outsourcing specific functions instead of maintaining large in-house teams, often reducing overhead costs. Strategically leverage low-cost centers of expertise.
Operational Efficiency
Streamline operations, apply best-practices and focus internal resources on strategic initiatives by leveraging G&L’s proprietary methodology.
Specialized Expertise
Extensive experience across multiple regulatory frameworks (FDA, EMA, MHRA, etc.), ensuring compliance in all target markets. Access to a global network of regulatory professionals helps with faster approvals and market entry.
Staff Augmentation
Trust G&L to provide the right resource, with the right skills, experience, location and price – for the right period of time.
Scalability & Flexibility
Easily scale your team up or down based on workload, project needs, or regulatory or quality demands. Short-term or long-term engagement options allow for rapid adjustments without long-term commitments.
Specialized Expertise
Experienced professionals with niche regulatory expertise without the time and cost of recruiting full-time employees. Augment your existing team with experts in specific regulatory areas like submissions, compliance, or market approvals.
Cost Efficiency
Avoid the long-term costs of hiring permanent employees (e.g., salaries, benefits, training, and infrastructure). Pay for resources only when needed, making it a cost-efficient option for projects with fluctuating demands.
Rapid onboarding and reduced hiring burden
Augmented staff are provided by G&L, reducing recruitment time and effort. These professionals often require less training since they already have industry-specific expertise.
Comparison of Models
Delivery Models
Off-Shore
Leveraging on low-cost centers of expertise, such as those in Mumbai, to drive cost efficiency. This approach is ideal for high-volume, multi-year engagements that require minimal direct interaction with clients. By leveraging economies of scale, companies can maximize price competitiveness while continuously improving processes and enhancing operational efficiency.
Near-Shore
A strategic alternative for organizations seeking cost-effective solutions while maintaining closer alignment with client time zones. Utilizing lower-cost centers in locations like Belfast or Barcelona, this approach is well-suited for high-volume, long-term engagements that benefit from time-zone proximity to client stakeholders. Near-shore setups create opportunities for continuous improvement and operational streamlining.
On-Shore or On-Site
Placing highly skilled regulatory professionals near or within key client locations, such as the U.S., U.K., or Canada. This structure is particularly beneficial for specialized or niche expertise, regulatory agency experience, and direct collaboration with client stakeholders. Proximity to on-site quality functions ensures seamless integration and alignment with client regulatory strategies.
Blended
This approach strategically combines off-shore, near-shore, and on-shore expertise to achieve optimal operational outcomes. By integrating cost-effective resources where appropriate, businesses can enhance price competitiveness while maintaining a strong focus on value-added activities. This flexible model allows for tailored regulatory solutions that balance cost efficiency with high-quality service delivery.
Experience you can trust
0+
20+
Years serving the industry. Est 1998
0+
100+
Markets covered worldwide
0%
91%
Of clients would recommend G&L
