FDA Compliance Law Group



FDA Compliance Law Group




222 State Street, Boston, MA




CONTACT US

FDA Compliance Law Group is a law-focused consulting firm dedicated to helping companies navigate the complex landscape of FDA regulatory compliance. As legal experts, we provide authoritative guidance in all stages of regulatory affairs, from product development and approval to post-market compliance.



Contact

Lawyerfda.com, 617 xxxxx

.



Background



Many small and mid-sized life sciences companies develop groundbreaking technologies—but lack the internal resources to support a full-scale regulatory affairs department. Navigating FDA requirements, managing submissions, and ensuring ongoing compliance can be overwhelming without seasoned regulatory leadership. For these companies, the ability to outsource regulatory strategy and compliance to trusted experts is not just practical—it’s essential. As experienced FDA regulatory attorneys, we provide strategic, efficient, and scalable support—so you can stay focused on innovation while we manage the regulatory path ahead.



Our Approach



We combine deep legal expertise with hands-on regulatory experience to deliver practical, results-driven solutions tailored to your business. Whether you're preparing a 510(k), PMA, BLA, navigating a warning letter, or building a global compliance program, we act as an extension of your team—without the overhead of a full-time regulatory staff.


Our approach is built on three core principles:


1. Strategic Alignment – We align regulatory strategies with your business goals to support faster approvals, mitigate risks, and position your company for growth or acquisition.


2. Legal Rigor – As FDA-trained attorneys, we approach every engagement with the precision and foresight needed to reduce enforcement risk and protect your interests.


3. Scalable Support – Whether you need short-term guidance or long-term engagement, our services are designed to grow with you.


We don’t just interpret regulations—we help you use them as a competitive advantage.



Who We Serve



We partner with innovators across the life sciences sector who need expert FDA regulatory guidance without the burden of building a large in-house team.


Our clients include:


• Startups and Early-Stage Companies – Navigating premarket submissions, clinical trial design, and go-to-market strategies while conserving capital.

• Small to Mid-Sized Manufacturers – Managing day-to-day regulatory operations, responding to FDA communications, and preparing for inspections.

• Private Equity and Venture Investors – Conducting regulatory due diligence, identifying portfolio risk, and strengthening compliance infrastructure post-acquisition.

• International Companies Entering the U.S. Market – Guiding foreign manufacturers through U.S. FDA requirements and helping them establish a compliant U.S. presence.


Whether you need one-time strategic advice or long-term outsourced regulatory leadership, we deliver experienced, responsive, and business-minded support.



Services





FDA Submissions Approvals



Expertise in preparing, reviewing, and submitting IND, NDA, and 510(k) applications, as well as PMAs. ​



Regulatory Strategy and Legal Counsel



• Regulatory Strategy and Legal Counsel: Developing compliant pathways for new drugs, biologics, medical devices, and other regulated products. ​



Risk assessment and Compliance Audits



Conducting in-depth compliance audits and risk assessments to ensure adherence to FDA regulations. ​



Labeling and Promotional Review



Ensuring all labeling, advertising, and promotional materials meet FDA requirements and avoid legal pitfalls. ​



Post-Market Surveillance and Reporting



Providing ongoing support for post-approval compliance, including reporting, monitoring, and recalls.​



Legal Representation and Advocacy



Representing clients in FDA hearings, legal matters, and appeals to resolve compliance issues effectively.



Responding to FDA Regulatory Letters



When your company receives an FDA 483 or warning letter, your response is more than just a formality—it’s a critical document that can influence regulatory outcomes and impact your company’s future. An FDA regulatory letter response can be seen as an admission to the government, making it essential to have legal oversight before submission.


Why Have an Attorney Review Your FDA Regulatory Response?


• Protect Against Unintended Admissions – A poorly worded response can be used against your company in future enforcement actions. We ensure your response acknowledges issues without over-admitting liability.

• Demonstrate Compliance & Corrective Actions – The FDA expects a clear, thorough, and strategic response. We help craft a response that satisfies regulatory expectations while safeguarding your legal position.

• Mitigate Risk of Further Enforcement – Insufficient responses can lead to Warning Letters, product seizures, injunctions, or even criminal liability. A legal review helps minimize these risks.

• Ensure Consistency with Past Statements & Regulatory Filings – Discrepancies between your response and prior communications with the FDA can raise red flags. We ensure your response aligns with previous statements to maintain credibility.


How Our Legal Experts Can Help


Our firm specializes in FDA regulatory affairs and legal risk mitigation. With extensive experience in handling FDA 483 responses, we provide:

✔ Comprehensive review of your draft response

✔ Guidance on legally sound corrective action commitments

✔ Strategic language to protect against unnecessary liability

✔ Assistance in demonstrating compliance while minimizing risk


Don’t Let a Mistake in Your Response Cost Your Business


An effective FDA 483 response can mean the difference between a routine follow-up and serious regulatory consequences. Ensure your response is legally sound and strategically crafted by working with our experienced FDA regulatory attorneys.





David M. Olsen, J.D., LL.M.



Principal Attorney





Global Life Sciences Leader | General Counsel | Regulatory Attorney | Entrepreneur

As a senior executive in the life sciences sector, I bring a unique combination of legal acumen, regulatory expertise, and entrepreneurial spirit. With a proven track record in navigating complex global regulatory landscapes, I have successfully driven strategic initiatives, ensuring compliance while fostering innovation.

Key Highlights:

• Leadership: Extensive experience in C-suite roles, providing strategic counsel to multinational life sciences companies. Skilled in aligning legal and business objectives to drive growth and operational excellence.

• Regulatory Expertise: Deep knowledge of FDA, EMA, and global regulatory frameworks, ensuring compliance across drug, device, and biotechnology product lifecycles.

• Entrepreneurship: Founder of innovative ventures in the life sciences sector, combining regulatory insight with business strategy to unlock new opportunities.
​
• Legal Excellence: Robust track record as General Counsel, managing legal risks, overseeing corporate governance, and leading cross-functional teams in high-stakes negotiations and litigation.

Areas of Expertise:

• FDA Regulatory Affairs
• Global Compliance Strategy
• Corporate Governance
• Mergers & Acquisitions in Life Sciences
• Intellectual Property Management
• Litigation & Dispute Resolution

Professional Philosophy:
​
Committed to advancing healthcare through strategic legal counsel and fostering innovation that improves lives globally.




Why Choose Us ?



At FDA Compliance Law Group, our team of seasoned attorneys and regulatory specialists offers a unique combination of legal acumen and regulatory insight. Our mission is to protect your innovation while navigating the legal frameworks necessary for FDA compliance, so you can bring safe, effective products to market with confidence.