Service
Regulatory Consultant
Storage service
Vicpharms Co.Ltd is Leading Regulatory and Registration Service provider in writing Dossier,DMF,CTD,ACTD,eCTD and compilation of all kind of registration files and submission.
We provide regulatory consulting and dossier solution for export registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).
Administrative Documentation (writing and review):
• Registration Application & Covering Letter
• Letter of Authorisation
• Legal & Administrative (GMP,CoPP, FSC etc) Documents
• Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
• Label and carton contents
• Global Patent Information and Literature for patented product
• PSUR (Periodic Safety Update Reports)
Technical Documentation (writing and review):
• Summaries – Quality, Clinical & Non-clinical
• Drug master file (S Part of Dossier)
• Clinical & Non-clinical Overview (Module 2)
• PDR, Process validation, AMV & Stability Studies
• Specification, Method of analysis & Certificate of Analysis of Raw materials & Packing Materials
• Specification, Method of analysis & Certificate of Analysis of Formulation product
• Module 4 (Non-clinical)
• Module 5 (Non-clinical)
Materials Management
We manage a broad range of materials from APIs and raw materials to finished
products. Our GSP warehouse utilizes fully controlled temperature like ambient temperature(15-25°C), refrigerated temperature(2-8°C), frozen (-20°C to -80°C).
These areas are all fully validated, continuously monitored, alarmed and offer a range of storage temperatures. In addition to our pharmaceutical storage, we can provide the collection, return and reconciliation of client’s material.
We also provide distribution of temperature controlled shipping for temperature sensitive products.
Cold Chain Distribution
We provide Cold chain distribution services via our GSP warehouse include
appropriate storage report,validated shipping systems like thermal monitoring systems, proper packing, in-transit temperature recording, time out of refrigeration (TOR) monitoring. We can arrange domestic and worldwide material distribution under above conditions.
Our cold chain experts have the experience and knowledge to manage temperature sensitive materials throughout the distribution process.
Document Support
We provides full documentation for material transaction history and current material inventory status through our unique ERP system. Each client has a dedicated project manager at Innoten who help create customized solutions and ensure projects are completed on time. Our team always concern top priority of client satisfactions.