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Regulatory Support Services
With expertise in custom synthesis, analytical services, and drug development.
We are here to support all your research needs by reducing the project timeline and cost.
Regulatory Strategy Development
We assist pharmaceutical companies in developing strategic regulatory plans tailored to their product development goals and target markets. Our regulatory strategy development services include:
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Assessing existing regulatory documentation and identifying gaps andareas for improvement to achieve compliance and streamline submissions.
Identifying the most suitable regulatory pathways (e.g., NDA,ANDA, BLA) and submission routes (eCTD, non-eCTD) based on product characteristics, indications, and market requirements.
Conducting risk assessments to identify potential regulatory risksand develop mitigation strategies to address them proactively.
Dossier Preparation
We specialize in dossier preparation for regulatory submissions, ensuring the accuracy, completeness, and compliance of regulatory documentation. Our dossier preparation services include:
Compiling and organizing regulatory documents, including CMC, nonclinical, and clinical data, into comprehensive regulatory dossiers.
Drafting and editing regulatory documents, summaries, and reports to meet the formatting and content requirements of regulatory authorities.
Performing thorough quality checks and reviews to ensure the accuracy, consistency, and compliance of regulatory submissions with regulatory guidelines and standards.
Submission Management
We manage the entire regulatory submission process, from pre-submission planning to post-submission follow-up, to ensure timely and successful submissions. Our submission management services include:
Preparing submission packages and compiling required documents and forms in accordance with regulatory requirements and submission guidelines.
Tracking submission progress and milestones, managing submission timelines, and coordinating with regulatory authorities to address queries and requests for additional information.
Providing post-submission support, including response preparation, regulatory correspondence management, and follow-up activities to facilitate regulatory review and approval.
Compliance Assistance
We offer ongoing compliance assistance and support to pharmaceutical companies to ensure continuous compliance with regulatory requirements. Our compliance assistance services include:
Monitoring regulatory updates and changes in global regulations, guidelines, and standards to keep clients informed and ensure proactive compliance.
Assisting clients in addressing regulatory deficiencies and implementing corrective actions and remediation plans to achieve and maintain compliance.
Providing guidance and support to prepare for regulatory inspections, including mock inspections, documentation review, and staff training, to ensure readiness and compliance.
Why ARSI Canada Inc.?
Choosing ARSI Canada Inc. for your regulatory support needs means partnering with a team dedicated to ensuring the successful approval and commercialization of your pharmaceutical products. Our regulatory expertise, strategic guidance, submission excellence, and continuous compliance assistance make us the ideal partner to navigate the regulatory landscape with confidence and achieve regulatory success.
Contact ARSI Canada Inc. today to access our comprehensive regulatory support services and embark on a successful regulatory journey for your pharmaceutical products.
