Simplifying Regulatory Compliance
FGS provides trusted regulatory solutions for the financial and pharmaceutical industries. Backed by decades of experience, we help organizations manage complex compliance requirements with accuracy, efficiency, and confidence.
See our services by industry:
Regulatory Services
Pharma Regulatory Services
A client-assigned customer service team will lead and manage every aspect of the creation, production and distribution process
We are a
integration partner.
Prescription Information
Management
From composition and design to printing, precision folding, inventory storage and PI swapping, we
specialize in helping pharmaceutical companies keep PIs accurate, compliant, and production-ready.
We can replace outdated PIs across multiple item types: sales and marketing, sample cartons, kits, leave-behinds, and more.
Reduce inventory complexity: Print once, store flat, and fold to multiple configurations for different packaging and marketing applications.
Drug Sample Tracking
Not only do drug samples require good manufacturing practices, but tracking and reporting to the FDA and DEA are also required. You will need a healthcare fulfillment partner that offers a robust monitoring system with agile tracking.
DemandOne manages sample distribution for some of the world’s largest healthcare companies.
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Direct-to-rep
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Direct-to-practitioner
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Sample accountability and inventory management
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Field tracking (HCP to HCP tracking)
Document Composition Services
Custom
Composition
Using client supplied Microsoft Word, Excel files and mark-ups, FGS will format and style the content to your pre-approved style and branding specifications.
Automated
Composition
FGS can utilize any number of data-feeds to create documents in minutes. This is ideal for data rich documents requiring constant updates. This can also integrate to a user-friendly web interface.
Edits and
Author Alterations
FGS is staffed around the clock to manage the alteration process. We understand that this is vital to supporting the legal, marketing and accounting review and auditing process.
Financial Regulatory Services
A client-assigned customer service team will lead and manage every aspect of the creation, filing, production and distribution process
SEC Compliance
As a full-service filing agent, FGS can convert a variety of file types into SEC EDGAR compliant HTML. Either as a standalone (EDGAR only) project or in combination with composition, FGS is ready and able to take on all of your SEC filing requirements. Oh, if you still want ASCII files… don’t worry, we can do that too.
.XML File
Several filing types can no longer be transmitted to the SEC as HTML or ASCII. Instead, they must be transmitted as an .xml file. Forms 3, 4 and 5, 13F’s, N-MFP, N-CEN, TA-1 and TA-2 are some of these filing types. Utilizing special templates and automation FGS can quickly populate these forms with client data and get them filed with the SEC.
XBRL
We offer XBRL tagging and taxonomy services with a client-accessed portal for project management, review, approval and collaboration. FGS provides the accounting expertise and experience to properly identify tags and advise clients.
Forms Management
We provide full forms management, creation and production services. Forms solutions (such as fillable PDFs) and web-based database driven techniques are also available.
Prospectus Solutions
FGS offers a full range of services to aid in the creation of statutory pros with summary pro creation on-the-fly, Statements of Additional Information (SAIs), and proxy creation.
Document File Conversion and Re-purposing
We utilize data-feeds to create documents in minutes – This is ideal for data-rich documents requiring constant updates and new version creation. This also integrates to a user interface to enable user-based content management and document creation.
Data-fed Composition
We provide full forms management, creation and production services. Forms solutions (such as fillable PDFs) and web-based database driven techniques are also available.
Web-based Content Management and Publishing
FGS has brought a powerful user interface, database and publishing engine to help companies store, manage, update, and publish regulatory documents of all kinds.
Web Hosting and Hosting Services
The SEC has established new rules for how documents must be hosted. FGS has invested in technologies to safely and securely host your documents while making them available to your investors, financial advisors, analysts and clients. Our robust, enterprise-wide, compliant, hosting solution can become your one central asset management solution to support all compliance, marketing, legal and sales requirements.