Expert Documentation and Dossier Services
Ensure your pharmaceutical processes meet regulatory standards with our expert documentation services.
Inconsistent Documentation: A Compliance Risk
Poorly managed documentation can lead to regulatory non-compliance, production delays, and increased operational risk. Our services help you streamline your documentation processes, reducing errors and ensuring compliance.
Our Documentation and PQS Approach
- Structured Documentation System: Well-organized systems for managing SOPs, STP, STS, PDR, MFR, batch records, and other essential documents.
- Document Control: Processes for reviewing, updating, and archiving documents.
- Change Control: Documented procedures to manage changes within PQS.
- Audits: Regular audits to ensure the PQS meets quality standards.
- Compliance with International Guidelines: Aligning PQS with International Guidelines for comprehensive quality management.
Dossier Preparation
Our Dossier Preparation service provides a comprehensive compilation of essential regulatory documents for product approvals. From quality and safety data to efficacy details, we ensure every element of the dossier aligns with international standards. Our service includes:
- Compilation of Regulatory Documentation: Preparation of quality, safety, and efficacy data tailored to specific regulatory body requirements.
- Structured Compliance Reviews: Dossier organization that meets the format and detail standards of regulatory authorities, minimizing approval delays.
- Global Standard Adherence: Compliance with international guidelines to facilitate smoother global product entry.
Our Dossier Preparation Approach
- Regulatory Knowledge: Understanding of regulatory requirements in different markets (e.g., FDA, EMA, WHO).
- Detailed Product Information: Providing comprehensive details of product composition, manufacturing process, stability studies, and clinical data.
- Quality Assurance (QA) Checks: QA verification of all documentation to ensure accuracy and completeness.
- Coordination Across Departments: Collaboration between R&D, regulatory affairs, and quality control departments.
- Format and Compliance: Ensuring the dossier is prepared in the correct format (e.g., CTD format) and compliant with regulatory standards.
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Why Choose Our Documentation and Dossier Services?
Improved Compliance:
Ensure all procedures align with regulatory requirements.
Efficiency:
Streamline processes for faster approval times.
Error Reduction:
Reduce the risk of miscommunication and procedural errors.
