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KLCRO offers unparalleled scientific, regulatory, and operational expertise coupled with a global presence to facilitate regulatory approval and market access for your product. Our comprehensive regulatory services encompass a wide array of activities and technical functions, including regulatory development, licensing, life-cycle management, and strategic regulatory planning. Leveraging advanced technology such as KLCRO’s regulatory information management systemwe employ process improvement techniques to ensure the highest quality of delivery.
You can benefit from our extensive experience preparing and overseeing regulatory applications in more than many countries. We can use and distribute clear, comprehensive regulatory intelligence that has been layered and confirmed with our significant, current expertise thanks to our own intelligence platform, KLCRO®RegView.
Rules and laws, procedures, and schedules
Industry customs
Regional and National disparities
Analysis of Regulations
Legal precedent
Rules or Instructions
Views and Recommendations
GLOBAL REGULATORY
INTELLIGENCY AND
INFORMATION
REGULATORY
DEVELOPMENT
EXPERTISE AND
GLOBAL STRATEGIES
NEW PRODUCT
LICENSING
AND MARKET
EXPANSION
MARKETED PRODUCT LIFECYCLE
MANAGEMENT AND COMPLIANCE
AD-HOC CLIENT SUPPORT
AND SPECIALIST CONSULTING
Our global reach provides local coverage in key countries, enabling us to apply up-to-date, robust regulatory intelligence to product development and registration strategies. We develop preemptive solutions for potential regulatory hurdles and ensure the quality of submissions to worldwide agencies to maximize the likelihood of successful review.
51 Offices Around the Globe
Offices with regulatory affairs presence, including clinical trial application (regulatory authority and ethics committee) submission handling.
Pakistan Mexico Philippines
KLCRO FLEX units provide functional outsourcing as a customizable solution that focuses on high quality, measurable outcomes and cost savings. This dedicated business unit focuses on a full range of regulatory services, including regulatory strategy and document preparation, publishing and lifecycle management.