Creating Order From Regulatory Uncertainty
FDA Regulatory Strategy, Quality Systems, and Compliance for Pharmaceutical and Medical Device Companies
For more than 30 years, Walljasper Pharmaceutical Consulting has helped pharmaceutical and medical device companies navigate the regulatory landscape with clarity, precision, and confidence. We don’t just advise on regulatory strategy. We build the systems, prepare the submissions, and solve the problems that stand between your product and the market.
Our approach is rooted in hands-on execution. From laboratory testing, manufacturing, and validation to FDA submissions and post-marketing compliance, we’ve done the work ourselves. That firsthand experience means we understand not just what regulators expect, but how to deliver it efficiently and thoroughly.
The regulatory landscape is complex. Getting it wrong can be costly.
Pharmaceutical and medical device companies operate in one of the most highly regulated industries in the world. Agencies like the U.S. Food and Drug Administration (FDA) require extensive documentation, validated processes, clinical data, and ongoing compliance to ensure products are safe and effective.
Common challenges include incomplete or incorrect submission data, lack of clarity around FDA expectations. These challenges also include delays due to missing validation or testing, failed inspections, and post-marketing compliance risks.
The reality is simple: you need execution experience, not just regulatory knowledge. That’s where we come in.
Meet Gina Walljasper
Founder | Regulatory & Quality Consultant
I bring over 30 years of experience across pharmaceutical manufacturing, quality assurance, and medical device regulatory strategy.
Gina Walljasper brings over 30 years of direct experience across pharmaceutical manufacturing, quality assurance, regulatory affairs, and medical device regulatory strategy. Her career began as a chemist in pharmaceutical laboratories, where she tested products firsthand and developed a deep, practical understanding of how products are developed, validated, and brought to market.
From the lab, Gina advanced into quality assurance leadership, spending more than 20 years working across manufacturing, validation, packaging, and compliance systems. She has led complex tech transfer initiatives across multiple sites worldwide, ensuring consistency, compliance, and operational alignment at scale.
Her expertise expanded into medical device space, where she has supported FDA 510(k) submissions, software-driven technologies, imaging systems, and comprehensive risk management strategies. On the clinical side, she has partnered with contract research organizations (CROs) conducting trials across multiple countries, navigating the complexities of global coordination and regulatory alignment.
Throughout her career, Gina has worked directly with the FDA, DEA, and other regulatory authorities, building deep regulatory insight along with a strong network of trusted partners and industry experts. This allows her to effectively manage multiple moving parts across highly regulated environments and support innovators and emerging companies in bringing their products to market.
Most consultants’ review documentation. Gina has authored the documentation, executed, and when required remediated the quality systems behind it.
A different approach to problem solving
Outside of regulatory work, Gina is drawn to interior design and hands-on home renovation. These projects require the same skills she brings to her clients: breaking down complexity, rebuilding structure, and creating something better, current, and more efficient. Whether she’s rethinking a room design or rethinking a regulatory strategy, the approach is the same. Identify what’s not working, build a clear plan, and execute until the result speaks for itself.
Why Walljasper Consulting
- Hands-on execution experience across laboratory, manufacturing, validation, and quality systems that translate directly into complete, thorough regulatory submissions.
- Deep dual-industry expertise spanning both pharmaceuticals and medical devices, including software-integrated medical technologies and complex systems.
- Strategy connected to reality. We bridge the gap between regulatory theory and real-world operations, ensuring your plan is one you can actually execute.
- Early risk identification. We spot potential issues before they become costly delays, saving you time, money, and momentum.
- Designated U.S. Agent services for non-U.S. firms looking to access the American market, supporting regulatory communication and FDA liaison needs.
We don’t just tell you what to do. We help you do it.
Who We Work With
Startup Companies
Navigating FDA and regulatory requirements for the first time, building compliant systems from the ground up.
Pharmaceutical Manufacturers
Ensuring quality systems, validation protocols, inspection readiness, and regulatory submissions meet FDA and global regulatory expectations.
Medical Device Companies
Developing products from concept to commercialization, including software-integrated and imaging technologies.
Physicians and Innovators
Transforming ideas into viable, FDA-approved products with a clear path from concept to clearance.
Investors and Venture Groups
Evaluating product viability, regulatory risk, and development readiness before making investment decisions.
Legal Teams
Requiring expert support in regulatory-related cases, discovery, and litigation involving pharmaceutical or medical device products.
Our Services
Regulatory Strategy, Quality Systems, and Compliance Solutions for Pharmaceutical and Medical Device Companies
From early-stage development through post-marketing compliance, Walljasper Pharmaceutical Consulting provides the regulatory expertise and hands-on execution support your team needs to bring safe, effective products to market and keep them there.
Service Offerings
Regulatory Strategy
We develop clear, actionable pathways for regulatory approval, including product classification, development planning, and submission strategy. Whether your product is a pharmaceutical, a medical device, or a software-integrated technology, we map the most efficient route to market based on your product’s specific profile and your business objectives.
FDA Submissions (510(k) and More)
We prepare, review, and support regulatory submissions with a focus on completeness, accuracy, and alignment with FDA expectations. Our team understands what reviewers are looking for because we’ve been on the other side of that process for decades.
Quality System Development
We design and implement quality management systems that meet FDA requirements and function in real-world operations. Our systems aren’t built for the shelf. They’re built to work on the floor, in the lab, and through every stage of your product lifecycle.
Designated U.S. Agent
For non-U.S. companies entering the American market, Walljasper Consulting serves as your official FDA liaison and Regulatory Correspondent. As your Designated U.S. Agent, we ensure clear communication with the FDA, regulatory compliance, and a streamlined process for market access.
Audit and Inspection Readiness
We conduct gap assessments, lead mock FDA inspections, and develop preparation programs to ensure your team and your systems are ready when regulators arrive. Our goal is not just to help you pass an inspection, but to build the confidence and infrastructure to sustain compliance.
Labeling & Promotional Compliance
We review product labeling and promotional materials to verify accurate representation of risks and benefits. Every claim must align with FDA requirements and the approved application.
Post-Marketing Compliance
Regulatory obligations don’t end at approval. We assist with adverse event reporting, coordinate product recalls when necessary, and support the ongoing compliance requirements that keep your product on the market and your company in good standing.
Investor and Legal Consulting
We perform regulatory due diligence and risk evaluations for investors, and legal teams. Whether you’re assessing the viability of a product, evaluating regulatory risk in a transaction, or providing expert support in litigation, we bring the technical depth and practical insight into every situation.
Clinical and Data Strategy
We ensure the right data is collected, structured, and presented to meet regulatory requirements and reviewer expectations. From study design support to data presentation strategy, we help you build a submission that tells a clear, compliant and tell a compelling story.
How It Works
A Clear, Structured Process From Assessment to Approval and Beyond
Every regulatory challenge is different, but our process ensures nothing gets missed. We bring structure and accountability to every engagement, guiding you from initial assessment through FDA approval and into post-marketing compliance.
Our Process
Regulatory Assessment
We start by evaluating your product, your needs, your goals, and your current regulatory status. This includes understanding your product’s classification, your development stage, your existing documentation, and any compliance gaps that could create risk down the line. The assessment gives both of us a clear picture of where you are and what needs to happen next.
Strategic Roadmap
Based on the assessment, we develop a customized regulatory roadmap. This isn’t a generic checklist. It’s a detailed, actionable plan tailored to your product, your market, and your timeline. The roadmap outlines every milestone, deliverable, and decision point between where you are now and where you need to be.
Submission Preparation
We develop the documentation, data packages, and supporting materials required for your regulatory submission. Every element is built with FDA expectations in mind, focused on completeness, accuracy, and clarity. Our goal is a submission that moves through review without unnecessary delays or requests for additional information.
FDA Interaction Support
When communication with the FDA is required, whether it’s a pre-submission meeting, a response to questions, or a formal interaction, we guide the process. We help you prepare clear, well-structured responses and ensure communications align with regulatory expectations.
Approval and Compliance
As your submission moves toward a decision, we ensure your organization is ready for what comes next. This includes preparing for any conditions of approval, verifying your quality systems are in place, and positioning your team for a successful outcome.
Post-Marketing Support
Approval is a milestone, not a finish line. We continue to support your compliance obligations, including adverse event reporting, labeling updates, recall coordination if needed, and ongoing regulatory requirements. Our involvement doesn’t stop when the approval letter arrives.
What to Expect
When you engage Walljasper Consulting, you can expect direct communication, clear timelines, and no surprises. Gina works personally with every client, bringing the same hands-on approach to your project that she’s applied across three decades of pharmaceutical and medical device work.
Ready to get started?
Schedule a consultation to discuss your product and your regulatory needs. We’ll give you an honest assessment of where you stand and a clear picture of what it will take to get where you need to go.