Regulatory Affairs and
Operations Services
 The PharmaReady Document & Submissions Management team provides regulatory consulting services to the international Life Sciences industry. We can help you understand the new and existing regulatory guidance, and ultimately facilitate approval for your product.
We have extensive experience with FDA, ICH, Health Canada and other International quality standards & regulations, meeting the needs of varying countries and regulatory agencies. We work closely with members of these Regulatory committees to gain an inside understanding of what the current regulatory thinking so that you can get approved.
- One stop regulatory submission management solution consisting of document management, dossier compilation, and submission project management
- Preparation, Submission and monitoring of Dossiers (NDAs , ANDAs, INDs, DMFs) both paper and electronic submissions using eCTD with FDA
- Regulatory Agent for FDA submissions [NDA, ANDA, IND, DMF, 510(k)]. This includes providing assistance in communication with FDA, responding to FDA questions concerning the Company’s products that are offered for import into the US, and assisting in scheduling FDA inspections of the Company’s manufacturing establishments.
- Expert Reviews, compilation, petition and notices, delivery of documents to FDA.
- Establish cost effective documentation system, including Drug Master Files (DMF), Validation Protocols, and Standard Operating Procedures (SOP). The documentation system is designed to meet FDA/EU and other regulatory standards.
- Guaranteed CTD and eCTD compliance with the latest regulatory guidelines and specifications
- SPL and PLR label conversion services for Package Insert submissions with FDA
- PIM Label conversions for EU
- Regulatory operations consulting including CTD structuring, document formatting, PDF conversions for Agency Submissions across the globe including, FDA, EU, Health Canada, Singapore and Australia.
- Paper to Electronic submission Assembly and Publishing
- Clone and reuse existing submissions for other global regulatory agencies
- ICH compliant eCTD Submission assembly for supported global agencies
- Support for QA validation and documentation
- Interpretation of ICH and regional agency requirements and specifications
- Ensure document and data compliance based on eCTD guidance and regulations
- Best Practice development and SOP support for eSubmission management
- Training Workshop to facilitate in-house implementation of electronic submissions using eCTD
Learn more about the fully integrated, regulatory compliant PharmaReady DMS, eCTD, SPL, and TRMS solutions.
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