Documentation Matters
When failed documentation costs millions in lost contracts, delayed regulatory approvals, or product liability exposure, you need specialized expertise that combines technical precision with strategic business acumen. We deliver regulatory submissions, winning RFPs/proposals, technical manuals,white papers and case studies for organizations where documentation quality directly impacts revenue and risk.
Valerie Braun | 30+ Years of Technical Writing Excellence

Valerie has produced more than 50 business cases and 35 business case studies, as well as corporate annual reports, growth plans, and strategic plans. Her case work focuses on clearly articulating situation, solution, and measurable results so decision‑makers can see the business impact of her clients’ work.
Technical writing services, FDA submissions, Government proposal writing, Regulatory writing, Technical documentation, Compliance documentation, Professional technical writer, 30+ years expertise, 70+ industries, Manual writing services, RFP responses, Technical manuals, Product and user manuals, White papers, Case studies.
Why High-Stakes Organizations Choose Our Services
Regulatory & Business Expertise
30+ years navigating complex federal compliance requirements—from FDA submissions to federal procurement regulations. We know regulatory language; we understand how regulatory reviewers and government evaluators assess documentation. We’re fluent in both compliance requirements and business strategy.
15% of clients working with us 10+ years; 85% for multiple projects
Risk Mitigation Focus
Documentation that reduces liability exposure and withstands legal scrutiny. Every deliverable is developed with awareness of regulatory standards (ANSI, ISO, FDA), legal defensibility, and compliance requirements. We identify gaps before costly deficiency letters, rejected proposals, or liability exposure.
25+ successful FDA submissions (510(k), PMA, Clinical Evaluation Reports)
Business Impact Orientation
We don’t just write—we position. Your documentation is strategic infrastructure supporting regulatory approval, contract wins, or liability defense. Track record of accelerating regulatory timelines, improving proposal win rates by 15-25%, and reducing product support costs by 30-40%.
40+ government contracts worth $150M+ aggregate value
Cross-Functional Integration
Regulatory, operational, and commercial documentation that work together. Deep industry experience enables us to understand your competitive landscape . When your regulatory strategy, technical documentation, and business positioning align, you compete at a higher level.
50+ technical manuals reducing support costs 20-40%
Our Five Core Services
Documentation for Successful Outcomes
Most organizations approach documentation reactively—handling regulatory submissions when FDA deadlines loom, rushing proposals when RFP opportunities appear, developing manuals after products launch. This fragmented approach creates inefficiencies, inconsistencies, and missed opportunities.
The most successful organizations treat documentation as strategic infrastructure—integrated systems where each component strengthens the others.
Whether your immediate need is regulatory approval, winning a government contract, or reducing product support costs, the most effective approach addresses documentation holistically. We help you:
- Accelerate regulatory timelines while ensuring FDA compliance
- Increase proposal win rates through strategic positioning and comprehensive criterion addressing
- Reduce support costs and liability through clear, standards-compliant documentation
- Build documentation ecosystems where regulatory, operational, and commercial content work together
Regulatory & Compliance Documentation Services
FDA Submissions | HIPAA Compliance | Government Approvals
Navigate complex regulatory approval processes. Whether it’s FDA clearance for medical devices, HIPAA certification for digital health, or banking regulator approval, we strategically position evidence so regulators understand your argument and approve faster.
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Track Record: 25+ successful FDA submissions | DHS compliance documentation | 42 CFR Part 482 compliance
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[Link: Learn More about Regulatory Writing]
Technical Manual Writing
Service Manuals | Installation Guides | Instructions for Use
Reduce liability exposure and support costs with regulatory-compliant documentation. Superior technical documentation differentiates your offering while meeting ANSI, ISO, and FDA standards.
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Track Record: 50+ technical manuals | 20-40% reduction in support costs | Simplified Technical English expertise
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[Link: Learn More about Technical Manuals]
RFPs & Proposals
Government Contracts | Strategic Positioning | RFP Win Rate Improvement
Increase win rates through strategic proposal positioning. Government contracts require more than technical competence—they require comprehensive criterion addressing and strategic differentiation.
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Track Record: 40+ government contracts | $150M+ aggregate value | 18% → 42% win rate improvement
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[Link: Learn More about RFP/Proposals]
White Papers
Thought Leadership | Lead Generation | Technical Briefings
Establish authority while advancing business objectives. From company briefings to industry thought leadership to regulatory positioning, white papers serve multiple functions and compound in value over time.
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Track Record: DHS policy briefings | Government and enterprise positioning | Feasibility studies
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[Link: Learn More about White Papers]
Case Studies
Business Cases | Sales Enablement | Past Performance Narratives
Demonstrate measurable results across regulated and unregulated industries. Case studies support government proposal competitiveness, enable sales conversations, and establish market authority.
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Track Record: 50+ business cases | 35+ case studies completed | Government past performance expertise
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[Link: Learn More about Case Studies]
Our Work In Action: Three Core Technical Writing Case Studies
REGULATORY WRITING CASE STUDY
510(k) Resubmission: From Deficiency Letter to FDA Clearance in 60 Days
A mid-sized medical device manufacturer’s initial 510(k) submission received an FDA deficiency letter citing insufficient clinical data and unclear substantial equivalence arguments. The company faced a six-month delay costing $300K+ in lost early-market revenue.
The Challenge:
The manufacturer had 60 days to respond comprehensively while the window of opportunity was closing. Standard regulatory experience wasn’t enough—they needed strategic positioning that would turn the reviewer’s concerns into an approval pathway.
What We Did:
We analyzed the specific deficiency letter language to identify reviewer concerns, restructured the clinical evaluation section with additional peer-reviewed literature support, strengthened the substantial equivalence argument with head-to-head comparison data, and refined the Instructions for Use to address labeling questions. The result was a comprehensive response strategy that made the company’s argument compelling to FDA reviewers.
The Results:
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FDA clearance achieved in 60 days
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Company entered market on original timeline, capturing first-mover advantage
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Estimated revenue impact: $2.5M+ over 18 months
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Regulatory timeline accelerated by 6 months vs. standard deficiency letter resubmission
RFP/PROPOSAL CASE STUDY
RFP Win: Engineering Firm Increases Proposal Win Rate from 18% to 42%
An architecture and engineering (A&E) firm was winning fewer than one in five government proposals despite strong technical qualifications and relevant past performance. The firm had experienced writers, but proposals were losing at the evaluation stage—not on technical merit, but on strategic positioning and compliance.
The Challenge:
The firm needed to understand why technically sound proposals were losing to competitors. The issue wasn’t the content; it was the strategy. Proposals weren’t directly addressing evaluation criteria, weren’t highlighting past performance advantages, and weren’t telling a compelling story about capability to execute.
What We Did:
We implemented a SARRM-based strategy (Situation, Action, Result, Relevance, Measurable): every proposal section directly mapped to evaluation criteria. We developed compliance matrices ensuring no criterion was missed. We created past performance narratives that demonstrated relevant experience without burying the message. We reframed technical descriptions to emphasize capability and risk mitigation, not just features.
The Results:
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Win rate improved from 18% to 42% (more than doubled)
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Average contract value increased due to better targeting of opportunities
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Proposal development time decreased (clearer process)
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Improved team confidence in competitive bidding strategy
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Estimated revenue impact: $3M+ over two years from increased contract awards
TECHNICAL MANUALS CASE STUDY
Service Manual Revision: 35% Reduction in Support Calls, Eliminated Liability Risk
A manufacturing company’s service manual—written years earlier by internal staff—generated constant customer support calls, field service complaints, and unresolved warranty issues. The company faced potential liability exposure: customers couldn’t follow procedures, service technicians improvised solutions, and equipment failures could result in injury claims.
The Challenge:
The existing manual covered procedures but wasn’t actually usable. Technical language was dense, steps were incomplete, diagrams were unclear, and safety warnings were buried in paragraph text rather than highlighted. Customers and technicians couldn’t follow instructions, leading to increased support costs, customer frustration, and liability risk.
What We Did:
We completely restructured the manual using Simplified Technical English (STE) standards: shorter sentences, active voice, numbered steps with visual callouts, safety warnings in highlighted sections, and clear troubleshooting guidance. We added diagrams and flow charts to supplement text. We tested procedures with both experienced technicians (who could catch gaps) and less experienced users (who could identify unclear language). The result was documentation that actually guided users through procedures correctly.
The Results:
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Support calls decreased 35% (fewer “how do I?” inquiries)
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Field service time decreased (technicians could follow procedures without workarounds)
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Warranty claims decreased (correct procedures prevented failures)
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Liability exposure reduced (clear safety instructions, documented procedures)
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Customer satisfaction improved (documentation actually helped)
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Estimated cost savings: $150K+ annually in support and warranty costs
Let’s Discuss Your Documentation
Challenge
Whether your immediate need is regulatory approval, government contract success, technical documentation quality, thought leadership positioning, or proof of your results, we’d like to understand your specific challenge and discuss how our expertise could help.
Which service are you most interested in exploring?
[Link: Regulatory Writing]
[Link: Technical Manuals]
[Link: RFP/Proposals]
[Link: White Papers]
[Link: Case Studies]