Documentation Services
CoralPT brings extensive and proven expertise to the table when it comes to preparing and reviewing documentation for pharmaceutical companies, catering to various audit requirements. Our forte lies in the development of Good Documentation and GMP Documentation practices tailored to meet the specific needs of our clients. The ultimate goal is to ensure conformity to established standards, and at CoralPT, we diligently achieve this objective.
Send InquiryDesigning Documentation Systems: Tailoring client documentation systems to meet international standards such as USFDA, WHO, EU, PICS, TGA, ICH Q7, and MHRA.
Comprehensive Document Portfolio: Preparation of documents including QMS (Quality Management System), Batch documentation, Validation documents, Recording forms, various formats, and SOPs (Standard Operating Procedures).
SOP Review and Support: Rigorous review of the firm's SOPs for performance and compliance. Provision of prototypes (templates) for a few SOPs, serving as a foundation for clients to expand their respective SOPs.
Master GMP Documentation: Assistance in preparing master GMP documentation wherever required for a robust quality management system.
Regulatory Compliance Check: Scrutiny of SOPs for regulatory compliance once prepared by the firm, ensuring technical accuracy and the availability of resources for execution.
Training Support: Training and enhancing the skills of the client's GMP documentation team to maintain and sustain GMP documentation consistently.
CoralPT collaborates seamlessly with experienced and highly skilled professionals and global GMP experts. Our approach is not only effective but also cost-efficient, ensuring that our clients receive top-notch documentation services tailored to their specific needs