Dossier Authoring Services - Overview
A well-built CTD dossier provides health authorities (HA) with complete technical and scientific information needed to evaluate the quality, safety, and efficacy of human medicinal drug products. Freyr’s dossier authoring expertise supports your product registration efforts by providing comprehensive, HA-compliant documentation and recommendations to meet the HA requirements.
From initial registration to market expansion of the medicinal products, Freyr experts ensure that all Regulatory requirements are met to avoid HA rejections, facilitating successful on-time approvals with all necessary support during HA review and maintaining compliance throughout the product lifecycle by authoring the high-quality dossiers that comply with global Regulatory standards and requirements.
The experience of Freyr’s experts in medicinal product registration ensures that product registrations are complete, Regulatory compliant, and positioned for on-time Regulatory approvals, enabling manufacturers and sponsors to achieve timely approvals and swift market entry.
Our dossier authoring services include:
- Submission of Full Applications
- End-to-End Product Registration
- Biologics Registration Services
- End-to-End NDA Submissions
- Hybrid Application Submissions
- CMC-Quality Modules
- CTD Templates
- Core/Master Dossier
- Market Expansions
- End-to-End DMF Registration
- End-to-End Excipient DMF Submissions
- Response to HA Queries
Freyr’s Dossier Authoring Services
Dossier Authoring Services
- Authoring, gap analysis, and submission of complete dossier for Regulatory applications
- Authoring of CTD dossiers/country-specific dossiers with a right-first-time approach
- Ensure “No Administrative Rejections” of the applications from HA
- Expertise and knowledge of all HA-specific requirements to handle each country-specific requirement for market entry
- Guidance for the gaps mitigation during the analysis of supporting documents and data
- Expertise in authoring and registration of all types of dosage forms and therapeutic category drugs
- Expertise in handling registration of all product types, like innovator drugs, biologics and biosimilars, generic drugs, drug-drug combinations, drug-device combination drugs, OTC drugs, APIs, excipients, and packaging materials
- Drafting of dossier-related correspondences with HA
- Preparation and review of all types of deficiencies from HAs respectively
- Expertise in handling all types of applications like NDAs, BLAs, NDSs, MAAs, country-specific dossiers, ANDAs, ANDSs, DMFs, ASMFs, and CEPs for all product types of registration
- Ex-FDA/EMA experts to support in finalizing the regulatory strategies and preparing the response to HA queries
- Providing Regulatory submission pathways and strategic guidance
- Comprehensive Regulatory roadmap on dossier submission procedures
- Thorough assessment of all supporting documents for their adequacy against country-specific requirements
- Specialized expertise in authoring and reviewing the content for drug-device combination products
- Specialized expertise in biologics/biosimilars/vaccines, NDAs, ANDAs, complex generics, hybrid applications, combination products, APIs, excipients, and packaging materials
- Thorough understanding and providing necessary guidance on preview, expedited review, CGTs, etc.
- Proactive in finding out the potential points initially to avoid RTR/RTF rejections to save application fees and time
- Specialized expertise in filing over-the-counter (OTC) drugs
- Identifying potential gaps and providing mitigation strategies and guidance to avoid major HA queries and rejections
- Timely support in response to submissions to HAs for on-time approvals
- Efficient standardized templatization and workflows
- Dossier authoring is supported by automation, which saves time and effort
- Proactive compliance monitoring to avoid potential findings
