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Regulatory Support
Briefing Books
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FDA/EMA
We prepare comprehensive briefing books for FDA and EMA meetings, including detailed documentation and strategic insights to support your regulatory submissions and interactions. Our expertise ensures that your presentation is thorough, clear, and effectively addresses regulatory requirements.
EAMS
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Early Access To Medicines Scheme
Our team assists in navigating the Early Access to Medicines Scheme (EAMS), providing support for applications and ensuring compliance with all regulatory guidelines. This service helps patients gain access to promising new treatments before they are fully licensed.
PIMS
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Patient Information Management System
We offer expertise in the implementation and management of Patient Information Management Systems (PIMS), ensuring accurate and secure handling of patient data. Our solutions are designed to meet regulatory standards and support clinical and regulatory needs.
PV - RMP
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Pharmacovigilance
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Risk Management Plan
Our pharmacovigilance services include the development and management of Risk Management Plans (RMPs), ensuring the safety and efficacy of veterinary drugs. We help you comply with regulatory requirements and effectively monitor and mitigate risks associated with your products.
Database Standardisation for FDA Submissions
Our team ensures that your clinical trial data is standardized and compliant with FDA requirements. We provide comprehensive support in database design, data collection, and data management, facilitating smooth and successful regulatory submissions.
CDP
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Clinical Development Plan
Our expertise in Clinical Development Plans (CDPs) helps you design and implement effective strategies for clinical trials. We ensure that your CDP aligns with regulatory requirements and supports the successful development and approval of your veterinary drugs.
Protocol Design
We offer specialized support in protocol design, ensuring that your clinical trials are scientifically sound and regulatory compliant. Our services include the development of detailed protocols that address study objectives, methodologies, and regulatory guidelines.
Inspection
We provide comprehensive support for regulatory inspections, including preparation, on-site assistance, and post-inspection follow-up. Our team ensures that you are fully prepared to meet regulatory standards and address any findings promptly and effectively.
Training & Courses
We offer training and courses on various aspects of regulatory statistics and programming. Our programs are designed to enhance your team's knowledge and skills, ensuring that you are well-prepared to meet regulatory challenges and achieve your development goals.