When navigating complex pharmaceutical or medical device litigation, nothing matters more than clarity and credibility. Whether you’re preparing for a product liability trial or need expert insight for FDA compliance, Sharlin Consulting provides unbiased evaluations—highlighting both strengths and weaknesses of your case with total transparency.
Our consulting services are trusted across the United States by attorneys, corporate legal teams, biotech startups, and major pharma manufacturers. With a specialization in biologics, medical device regulation, FDA compliance, and pharmaceutical litigation, we bring decades of experience to every expert opinion we issue.
Why Unbiased Expert Witness Opinions Matter in Pharma and Medical Device Cases
The Risks of One-Sided Case Assessments
Too often, expert witnesses are chosen to simply “validate” a client’s position. But this approach can backfire—especially under legal scrutiny. If weaknesses are uncovered during deposition or trial by the opposing counsel, credibility is lost.
That’s why the value of an FDA regulatory expert witness who provides a balanced view cannot be overstated.
Why Legal Teams Value Balanced Opinions
Balanced doesn’t mean indecisive. It means objectivity, and objectivity builds trust with judges, juries, and regulatory bodies. When an expert witness can defend their findings confidently—because they’ve also identified potential weaknesses early on—it strengthens the legal team’s strategy.
How Sharlin Consulting Ensures Objectivity
At Sharlin Consulting, we work independently of any bias or agenda. Our mission is to offer a clear, informed perspective—grounded in regulatory science, current FDA policy, and years of litigation experience. We frequently identify issues missed by internal reviews or biased experts.
Meet Sharlin Consulting: Trusted FDA Regulatory & Compliance Experts
Who We Are and Who We Serve
Based in Washington, D.C., Sharlin Consulting serves clients across the United States. We provide FDA regulatory expert witness services as well as compliance consulting to law firms, pharmaceutical companies, medical device manufacturers, and biotech organizations.
Core Focus Areas: Biologics, Medical Devices, and Pharmaceuticals
We specialize in:
- Biologics: including monoclonal antibodies, gene therapies, and biosimilars
- Pharmaceuticals: from small-molecule drugs to combination products
- Medical Devices: both Class I-III, with a deep understanding of 510(k), PMA, and post-market obligations
Our Track Record in Federal and State Courts
Our experts have testified in over 100 legal cases, including product liability claims, patent disputes, and compliance violations. We’re frequently called to opine on matters involving FDA warning letters, recalls, and adverse event reporting failures.
Comprehensive Evaluation of Case Strengths and Weaknesses
Methodology Backed by Regulatory Knowledge
Our evaluation process includes:
- In-depth review of product history and FDA correspondence
- Analysis of internal communications and adverse event reports
- Cross-referencing against current and historic FDA regulations
This ensures no stone is left unturned. We look beyond the surface, uncovering issues in documentation, quality systems, or labeling that could affect litigation outcomes.
Case Studies: From Dismissal to Settlement
Here’s an example:
A leading law firm engaged Sharlin Consulting to assess a medical device-related injury claim. Our early evaluation identified labeling discrepancies and inconsistent training documentation, leading to a favorable settlement before trial.
In another instance, we helped a client dismiss a biologics-related case entirely by demonstrating that the product complied fully with FDA post-approval reporting requirements.
Risk Reduction Through Early-Stage Evaluation
Don’t wait until trial prep. Engaging an expert early means:
- Lower litigation risk
- Better negotiation leverage
- Stronger case positioning
Specialized Services for High-Stakes Litigation and Compliance
Pharmaceutical Expert Witness Testimony
Our pharmaceutical expert witnesses cover:
- Drug development timelines and regulatory pathways
- Labeling and promotional compliance
- Risk Evaluation and Mitigation Strategies (REMS)
We provide expert testimony, report drafting, and deposition support, all designed to clarify complex pharmaceutical regulatory issues in simple terms.
FDA Compliance Consulting for Biologics and Devices
Whether you’re dealing with a 483 Observation, Warning Letter, or product recall, our FDA compliance consultants bring order to chaos. We help clients address:
- Corrective and Preventive Actions (CAPAs)
- Quality System Regulation (QSR) compliance
- Biologics License Application (BLA) process alignment
Navigating Medical Device Regulation with Confidence
For companies bringing new technologies to market, we provide:
- Medical device regulation strategy consulting
- Risk classification analysis
- 510(k), De Novo, or PMA pathway guidance
We also assist with clinical trial design and interactions with CDRH (Center for Devices and Radiological Health).
Frequently Asked Questions About Expert Witness and FDA Consulting Services
What Makes a Strong Expert Witness Report?
A great expert witness report is:
- Thorough and transparent
- Aligned with current FDA regulations
- Capable of standing up to cross-examination
We include citations, analysis of the regulatory landscape, and full disclosures to ensure credibility.
How Early Should You Engage a Regulatory Consultant?
Immediately after case intake or pre-litigation. This allows your team to:
- Shape the narrative
- Address gaps in compliance
- Avoid overcommitting based on assumptions
What Sets Sharlin Consulting Apart?
- Neutral evaluations – we don’t just “take your side”
- FDA-insider experience – our consultants bring real-world knowledge
- Cross-disciplinary knowledge – covering pharma, biotech, and devices
Key Takeaways
- Sharlin Consulting provides unbiased, expert evaluations for pharmaceutical, biologic, and medical device litigation.
- We identify both strengths and weaknesses, allowing legal teams to build better cases.
- Our team includes FDA compliance consultants and expert witnesses with experience in federal court and regulatory defense.
- Early-stage consulting saves time and reduces legal risk.
Ready for Expert Regulatory Insight? Let’s Talk.
If you’re facing a high-stakes FDA compliance matter or preparing for litigation involving pharmaceuticals, biologics, or medical devices, Sharlin Consulting is here to help.
👉 Schedule a consultation today or call us directly to speak with one of our expert consultants.
