Regulatory Operations Managed ServicesEnhancing the quality and efficiency of regulatory submissions
Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations
The Emergence of New Systems, Processes and Skill Sets
Growing Compliance and Expansion ChallengesMore than ever before, life sciences organizations are being challenged to bring new and improved products to market faster, with fewer resources and while operating in an environment where failure to comply with ever evolving regulatory requirements can result in costly penalties. In addition, organizations are expanding into new geographical regions due to various reasons such as business expansion, mergers and acquisitions and extension of product longevity. This need to cater to disparate requirements across regions can, in many cases, slow down processes and reduce operational efficiency and profitability, while delaying time-to-market of these product.
Furthermore, regulatory mandates are becoming more stringent and the need for automation, technology, process excellence and global knowledge is paramount. Great strides have been made within the industry to harmonize these requirements and the adoption of standards like Common Technical Document (CTD), Electronic Common Technical Document (eCTD), and non-eCTD Electronic Submissions (NeeS) have simplified and streamlined the interactions with health authorities. In order to comply with the evolving regulatory mandates, cope with higher volumes and manage the resources that are spread across multiple geographies, organizations are turning to outsourcing and are partnering with vendors who specialize in regulatory affairs and operations.
Successful, compliance-driven companies are optimizing processes, adopting standards and deploying technology solutions with the global market in mind. Electronic submissions are becoming a way of life, not only from a regulatory standpoint but also from an efficiency standpoint. eCTD software transforms many of the previous manual processes and reduces the resource requirement; however, new systems, processes and skill sets have emerged.
Sciformix Regulatory Operations Managed Services helps our clients in this transformation by achieving operational excellence through optimized processes, thorough understanding of standards and well-trained experts. When time is short and flawless execution of the regulatory submission process is critical, a trusted partner can make all the difference in meeting deadlines, ensuring compliance with regulatory legislation and guidance, and ultimately in obtaining timely approvals.
Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations
Streamlined ProcessWe recognize the importance of a well-planned submission strategy and the impact it can have on gaining operational efficiencies, eliminating excessive rework, shortening the review cycle and avoiding additional costs – all barriers to achieving operational excellence. Our clients trust Sciformix to oversee, facilitate and optimize the entire submission process – from original application through post-approval lifecycle maintenance. Our shared resources model allows us to easily scale up and down depending on volume fluctuations.
As part of our Regulatory Operations Managed Services, we monitor key metrics and results that focus not only on quality and compliance, but also efficiency – such as submissions processed per year, cycle time, lead time, touch time, number of defects, first pass acceptance rate, etc. – ultimately offering regulatory operations cost advantages.
Benefits
Sciformix offers a complete range of tailored services to meet the needs of any regulatory operations project, regardless of size or timescale. Our Regulatory Operations Managed Services span the planning and assembly of submissions, document creation and approval, publishing, viewing and navigation, archiving, and submissions tracking and lifecycle management. In addition, we facilitate the coordinated management of all paper and electronic submissions, including both eCTD and non-eCTD electronic submission formats.
Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations
SolutionOnce content is stored electronically, it can be readily accessed and repurposed, thereby reducing associated administrative overhead and expediting companies’ speed to market.
Whether you require full-scale sustainable outsourcing of publishing activities or purely support related to eCTD dossier preparation or submission, Sciformix’s experienced Regulatory Operations and Publishing team is able to provide an efficient and cost-effective solution.
Regulatory consultants work with clients to help build a comprehensive strategy for regulatory affairs oversight and implementation.
Medical writers author Clinical Study Reports (CSRs) and submission components
Document specialists bring everything together for component publishing and work with the authors and contributors of CSRs to support the publishing of all types of documents. They set up virtual documents and link in all the final documents that are to be published, ensuring that they are submission ready.
Submission managers work with team members on large submission projects that require documents from all 5 eCTD modules, ranging from 500-10,000+ documents. They are responsible for each module by ensuring that all timelines are met and all documents are collated and ready for submission.
Benefits
Medical Writers
Consultants
Document Specialists
Submission Managers
People Expertise
Improved productivity
Resource optimization and scale
People expertise
Highest level of quality and compliance Continuous improvement opportunities
Faster review/approval cycle
Turnkey lifecycle management
via operational excellence, LEAN processes and workflow harmonization
via optimized workflows and automated processes
via improved project management and workload visibility
to manage workload volatilityfrom IND to post-approval maintenance
with deep regulatory operations knowledge
due to centralized oversight and tracking
Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs
USA | India | Philippines
Sciformix Corporation is a global scientific process organization (SPO) that partners with life science companies to develop, launch and sustain medical products that aim to improve the quality of healthcare worldwide. We collaborate with our clients through the entire product development lifecycle to provide a full range of services from study design to post marketing surveillance and commercialization support.
Trusted Services. Built on Science.
Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations
Sciformix Corporation1500 West Park Drive, Suite 210Westborough, MA 01581 USAPhone : 1 (877) 576-5005Fax : 1 (508) 302-6520Email : [email protected]
www.sciformix.com
large submission projects that
Regulatory Operations Managed Services
Phase 1 Phase 2 Phase 3 Post-Approval
Regulatory OperationsConsulting
Submission management for worldwide agencies
Authoring
Scientific review
Approval
Publishing plans for all submission types
Electronic and paper submission planning
Formatting of documents
Ensure documents are submission ready
Create submission virtual document (vDocs) and link all submission components to vDocs
On-time submission by working with team members (authors, doc control, publishing, etc.)
Manage submission tracking tool on major submissions
Quality check submission output
Ensure all components of the submission are accounted for and published via tracking tool
High quality submission output
Archive submission output
Content Creation
Document Control
Submission Management
Publishing & Archiving
