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Pharmaceuticals

Global / Country Specific Submission

Navigating the complex landscape of regulatory requirements, Reglysis offers comprehensive solutions for global and country-specific submissions. We ensure that all documentation, from initial applications to post-approval updates, is meticulously prepared and compliant with local and international standards. Our expertise in global and regional regulations helps streamline the submission process, facilitating faster market entry and smoother post-market maintenance.

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Preparation of Regulatory Dossiers​

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Local Regulatory

Liaison​

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Management of Product Registration & Renewals

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Variation & Amendment Filing

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Electronic Common Technical Document (eCTD) Preparation and Submission

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Digital LabeCoordination of Post-Approval Changesling & QR Code Integration

Safety

Effectively manage adverse events that arise after your product's launch with Reglysis comprehensive solutions, featuring advanced technology and a robust service portfolio.

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Medical Monitoring

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Global & Local Literature Search

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Periodic Safety Reports

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Case Processing

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Database Management

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Electronic Submissions

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Risk Management

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​QPPV (Qualified Person for Pharmacovigilance) Support

Class Labeling & Artwork

Reglysis specializes in creating compliant labeling and artwork for pharmaceutical products, ensuring they meet global regulatory requirements and reflect current safety standards.

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Label Content Development & Review

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Regulatory Compliance Checks for Labeling

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Creation & Update of Patient Information Leaflets (PIL)

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Packaging Artwork Design & Adaptation

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Multi-Language Labeling Coordination

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Digital Labeling & QR Code Integration

Review & Updates

Reglysis provides thorough review and update services to ensure that all regulatory documents, product information, and labeling remain current and compliant with the latest guidelines and regulations. We conduct regular assessments to identify necessary updates and implement them promptly, minimizing risks associated with outdated information. Our proactive approach helps maintain product safety, supports regulatory compliance, and ensures seamless communication with stakeholders.

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Regulatory Document Review & Gap Analysis

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Labeling and Artwork Updates

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Periodic Safety Update Reports (PSUR) & Periodic Benefit-Risk Evaluation Reports (PBRER)

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Clinical and Safety Data Assessment

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Impact Analysis of Regulatory Changes

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Compliance Audits & Corrective Actions

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Post-Market Surveillance Review

Post-Approval Support

Regulatory approval marks not the end, but the beginning of a critical phase where maintaining compliance is as vital as achieving it. At Reglysis, we continue to provide essential support post-approval, ensuring your product remains compliant as regulations evolve.

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Labelling Updates

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Risk Management and Safety Reporting

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​License Renewals & Lifecycle Maintenance

Clinical & Nonclinical Overviews

Reglysis provides comprehensive Clinical and Nonclinical Overviews to support regulatory submissions and product development. These overviews are detailed evaluations of clinical and preclinical data, assessing the safety, efficacy, and quality of a product. Our experts compile and interpret this data to ensure it aligns with regulatory standards, supporting successful submissions and informed decision-making throughout the product lifecycle.

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Compilation of Clinical Study Reports (CSR)

 

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Analysis of Preclinical Toxicology & Pharmacology Data

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​Benefit-Risk Assessment for Clinical & Nonclinical Data

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Preparation of Integrated Summaries of Safety (ISS) & Efficacy (ISE)

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Quality Overview of Manufacturing Data

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Literature Review & Data Integration

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Expert Commentary for Regulatory Submissions

Partner
With Us

By partnering with Reglysis, you ensure that your product progresses smoothly from development to market, minimizing delays and expediting regulatory approvals.

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