Gene therapy products: regulatory expectations and challenges for the industry
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Confidence Beyond Compliance
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing.
Modern Regulatory Operations is about proactively implementing efficient information management, scalable operational excellence, and innovative digital solutions like regulatory automation.
For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.
Whether working towards FDA submission, EMA submission or any other regulatory submission — our proven methods, extensive expertise, and open creative mindset cultivate long-term client relationships and success.
Expediating approximately 10,000 worldwide regulatory submissions in all formats every year, we continually enhances its practical experience with forward-thinking technologies. In addition to partnering with Veeva Systems and Lorenz, our proprietary SmartPHLEX platform offers tailor-made technological solutions.
As an active member of the international regulatory operations community, we regularly contribute to conferences and seminars to help guide thinking around subjects such as RIM/Regulatory Information Management, eCTD /electronic Common Technical Document submissions, and more.
Harness the industry leading perspective on global regulatory submissions. Add the unrivaled experience and invaluable insight of us to your team today.
Even today, much regulatory information is hosted in electronic documents—primarily in MS Word or PDF formats—which are still the basis for regulatory submissions.
That means all documents must comply with the specific submission requirements of the targeted health authority, such as the FDA, EMA and others.
We offer a customizable eCTD service of high quality, fast and competitively priced document formatting solutions. These services combine the proficiency of pre-publishing experts with the efficiency of automated tools and processes.
It is never too early to focus on accuracy and adherence. We provide a full suite of document templates for ICH regions and beyond to easily ensure that all CTD/Common Technical Document formats are correct.
This template suite includes predefined heading styles, fonts, margins, table formats and more—allowing authors to focus on content rather than format. In addition, a user-friendly toolbar offers one-click functionality, a user guide, and full support services.
eCTD Laundry Services
- Formatting documents in MS Word and PDF
- Managing and applying templates in MS Word
- Replacing/transferring standard text and logos in MS Word templates
- Performing submission readiness QC and communicating/correcting findings (if applicable)
- OCR scanning of paper documents
- Converting documents to PDF format
- Creating bookmarks and internal hyperlinks for each PDF document
- Performing document-level publishing QC including internal bookmarks and hyperlinks
We offer Full Lifecycle Management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA, MAA, ANDA, DMF and more) and lifecycle maintenance.
Our regulatory affairs professionals are fluent in a variety of electronic formats, including eCTD/electronic Common Technical Document and SPL/Structured Product Labeling.
With more than 2,500 eCTD submissions published annually — our teams provide confidence and peace-of-mind to clients around the world.
We can support you with the following solutions:
Submission Planning and Tracking with Regulatory Project Management
- End-to-end planning, coordination, and execution of major applications worldwide
- Developing/managing timelines, facilitating meetings, planning/managing communication, accelerating deliverables, assessing/mitigating risks, executing plans
- Completing simultaneous submissions to multiple regions with minimal document re-work
Electronic Submissions Processing, Publishing and Submission
- Electronic publishing of high-quality regulatory submissions utilizing eCTD software
- Providing submissions to global health authorities
- Adhering to assigned timelines for global regulatory submissions
When it comes to RIM/Regulatory Information Management, we combine digital innovation with extensive experience and ingenuity.
In partnership with the highly regarded software companies, Veeva and Lorenz – we enable clients to optimize their processes, configure systems to maximize benefits, and reduce the operational challenges of validated GxP-relevant software systems.
With a deep understanding of the unique challenges and needs of our clients, our Regulatory Operations consultants are able to craft optimal processes that boost technological advantages while managing data in ways that are compliant and efficient.
All of these processes are bundled into our Regulatory Systems Governance solutions and provide a comprehensive, worry-free way for clients to navigate the Regulatory system landscape.
Of course, these services also include appropriate handling with Regulatory data standards, such as XEVMPD, IDMP/SPOR, and SPL.
We can help you:
Select and Implement A Regulatory Solution
- Providing project management and subject matter expertise
- Defining user requirements and supporting vendor selection
- Offering consulting on process and configuration, based on our Best Practices
- Supporting data normalization, migration and import
- Supporting computer system validation acc. to 21 CFR Part and GAMP 5
- Providing training, change management and (post) Go-Live support
Operate and Improve Your Existing Regulatory Systems and Processes
- Supporting system and data maintenance
- Supporting system and business administration
- Providing change request handling, release management and continuous testing/validation activities
- Offering operational data entry services, including XEVMPD, IDMP/SPOR, SPL
- Enhancing process and operational excellence, based on real world experience
- Ensuring data reconciliation and data quality measures
- Providing audit and inspection support with appropriate queries and reports
While we have an impressive track record of supporting clients all over the globe in the transition to eCTD, as well as in complying with EMA’s XEVMPD requirements — we constantly look toward the future.
Development and progression of standards in the domain of Regulatory Affairs continues to rapidly evolve. And as eCTD is implemented in more countries, its next major version — eCTD 4.0 — is knocking at the door.
IDMP and SPL are also progressing in leaps and bounds. In fact, some promising new digital technologies require structured data formats, standardized data models and a unique and harmonized terminology.
We actively contributes to the development of new standards by engaging in industry associations and health authority working groups to help design the brave new world of IDMP, XEVMPD, eCTD v4.0, new regional eCTD (e.g. China eCTD) and other electronic submission formats (e.g. EAEU eCTD.)
Our experts remain in close contact with local consultants, covering the entire scope of Regulatory Intelligence in the field of Regulatory Data and Submission Standards.
We can support you with the following solutions:
Operational Support
- Publishing and submission for human medicines in eCTD format for all ICH regions and observers: EU, US, Japan, Canada, Switzerland, China, and others
- Electronic publishing and submission in any electronic formats for non-ICH regions: EAEU eCTD (EurAsian Economic Union), South Africa, Saudi Arabia and Gulf region, and others
- Electronic publishing and submission for veterinary medicines: VNeeS, CVM eSubmitter, and others
- Data entry and data submission for XEVMPD, IDMP, SPL, and other formats as needed
Strategic Advice and Implementation Support
- Assessing impact of new data and submissions standards on systems, processes, and organization
- Providing implementation guidance for new data and submission standards
Related Resources
Related Services
- ANDA Withdrawals
- Digital Health Questionnaire
- Global Procedure Management
- Health Authority / Agency Interaction
- Healthcare Compliance and Medical Approval
- MAA / NDA Submissions
- Marketing and Labeling Activities
- Scientific, Regulatory and Technical Writing
- SMART MDR
- SMARTCHECK
- SMARTCHECK MDR
- SMARTCHECK-MDR
- SMARTDECISIONS
- SMARTPHLEX
- SMARTTRACE
- Tobacco and Vape Products
What our clients say
Provided honest feedback and collaborative working solutions to obstacles
South Korea based medium sized company
Manager
Manager
Worked with us and our contractors to help us achieve our tight targets, operate with our systems and procedures and are considered invaluable part of our team
US based large development group
VP Regulatory / Quality
VP Regulatory / Quality