Regulatory Operations
offering comprehensive solutions for your document & publishing needs
Experience & Quality
Our team has significant experience in regulatory publishing and a successful track record with various types of submissions including but not limited to:
- INDs and CTAs at all stages of development
- BLAs
- Amendments
- Master Files
- DSURs
- Protocols, Informed Consents, Investigator’s Brochures Agency
- Briefing Packages
Lincoln Publishing Solutions offers a wide range of regulatory document and submission publishing.
We format documents and publish submission ready files based on agency requirements and industry best practices.
We pride ourselves on delivering only the highest quality publishing for our clients.
Publishing Services
- Standard and Custom Word Templates
- Publishing of Word and PDF documents and associated linking
- eCTD compilation
- Submission through ESG (Electronic Submission Gateway)
Regulatory Operations may also provide publishing services for other types of documents that may not be regulatory submission related, such as:
- creation & publishing of presentations
- summaries
- articles
- guides
- business proposals.
Regulatory Operations
- Work in collaboration with various departments in identifying areas for improvement in documentation management and control for client’ company records.
- Analysis, selection and project management of software purchases such as EDMS, eCTD publishing software, etc. including various phases of installation and validation.
- Create training programs to include overall training plan, SOPs, presentations, user assessments, and hands-on activities.
- Review and negotiate legal contracts and Scopes of Work.
- Create various Word templates for Style and Content.
- Conduct Word Training sessions to cover various miscellaneous helpful tips, basic formatting of documents including styles, TOC, captions etc. to assist authors as they create content.
- Develop and implement new document processes, procedures and tools to increase efficiency.
- Create, restructure and organize company document filing structure and content management.
- Work with various departments to help facilitate the implementation of new IT initiatives.
Other Services
Along with our partners, we are able to provide specific discipline leadership or support, or take more of a multi-disciplinary, streamlined, one-stop shop approach. Areas of expertise include:
- Global regulatory affairs strategy and content (especially FDA CBER and CVM)
- CMC
- Process Development and cGMP-compliant manufacture
- Translational R&D (e.g., IND-enabling studies), technical/product/platform/
regulatory diligence activities - Quality Assurance & Quality Control
Contact
Paulina Hayes
Owner & Chief Consultant
- 201-615-1772
- paulina@lincolnpublishingsolutions.com
- www.lincolnpublishingsolutions.com
