Where Quality Systems Meet Regulatory Intelligence
Engineering Regulatory Success for Devices, Diagnostics & Combination ProductsPrecision Regulatory Consulting LLC helps Pharma, Biotech, and MedTech teams simplify FDA, EU MDR/IVDR, QMSR, AI in MedTech, and Combination Product challenges through practical regulatory and quality strategy.
Specializing In:
FASTER REGULATORY APPROVAL
We specialized in cutting red tape to help you get faster regulatory approval for your products
ADAPTING TO CHANGING REGULATIONS
Our expertise will help you adjust your strategy to changing regulatory environment
PRECISE COMPLIANCE WITHOUT DELAYS
We will provide ultimate compliance to all global regulations
COMMITMENT TO HIGEST QUALITY CONSULTING
We focus on the WHY before the What and How and fosus on what is important using the 80/20 rule. We guarantee a 30$ ROI by reducing waste in your process resulting in savings of time and money in your organization.
Why Choose Us?
Unmatched Experience
With over 25 years of experience in global quality systems and regulatory compliance, Leonel has played a crucial role in the success of a wide range of high-impact products, from injectables to transcatheter heart valves. Whether working with startups or Fortune 100 companies, his extensive knowledge ensures that each client gets personalized, strategic advice to speed up product development, approvals, and strengthen compliance.
Client Centric Solutions
At Precision Regulatory, we put your needs first. Whether you’re navigating FDA or EMA regulations, or fine-tuning your quality management systems, our hands-on approach ensures that our solutions are tailored to your product’s lifecycle, compliance objectives, and market demands.
Regulatory Strategy and Complaince
We develop detailed regulatory strategies, guiding you through every step—from IND submissions to BLA approvals—while keeping you in line with FDA, EU IVDR, EU MDR, and ISO standards.
Quality Management Systems (QMS) and Audit Readiness
We specialize in building and refining QMS to ensure full compliance, minimize CAPAs, and help you ace audits in all markets.
Product Development Support
From concept to commercialization, we help you maintain product quality and reliability throughout development, offering expertise in combination products, pure devices, invitro diagnostics, biologics, and cutting-edge digital health technologies.
Industries We Serve / Expertise
At Precision Regulatory Consulting LLC, we specialize in providing regulatory and quality management support to highly regulated sectors. With over 25 years of experience, we help companies in the following industries navigate complex compliance requirements to bring innovative, safe products to market:
Biotechnology
Overview:
Biotechnology companies face unique regulatory challenges, especially as they develop products involving advanced biologics, biomarkers, and genetic engineering. We bring expertise in managing biologic submissions, risk management, and ensuring compliance with FDA, EMA, and global standards.
Key Areas of Support:
• Biologic License Applications (BLAs)
• Gene Therapy and Cell-Based Products
• GMP Compliance for Biomanufacturing
• Risk-Based Quality Systems for high-stakes environments
Benefit:
Accelerate regulatory approval and maintain compliance in an evolving biotech landscape.
Pharmaceuticals
Overview:
Our services support every stage of pharmaceutical product development, from clinical trials through commercial production. We specialize in regulatory strategy, quality oversight, and lifecycle management for both traditional pharmaceuticals and complex combination products.
Key Areas of Support:
• IND, NDA, and ANDA Submissions
• Good Manufacturing Practice (GMP) Audits and CAPA
• Clinical Quality Assurance and Regulatory Strategy
• Product Quality Reviews: Stability Testing and Method Validation
Benefit:
Reduce time to market while ensuring rigorous compliance and product quality.
Medical Devices / Diagnostics
Overview:
For medical device companies, we offer in-depth knowledge of quality system requirements, including ISO13485, IVDR, MDR, and FDA QSR. We guide clients through regulatory submissions, design control, and validation to ensure devices meet safety and efficacy standards.
Key Areas of Support:
• Design Controls and Human Factors (ISO 13485, FDA)
• Risk Management (ISO 14971)
• 510(k), PMA, and CE Marking 510(k), Pre-market Approval (PMA)
•Post-Market Surveillance and CAPA
Benefit:
Improve audit readiness, minimize compliance risks, and achieve faster market access.
Combination Products
Overview:
Combination products pose unique regulatory and quality challenges as they integrate drug, biologic, and device components. Our expertise in combination product development and compliance ensures seamless integration across components to meet dual FDA and EMA requirements.
Key Areas of Support:
• Drug-Device Compatibility and Clinical Studies
• Quality Management Systems for Combination Products
• FDA Combination Product Submissions and EMA Registration
• Risk Management (ICHQ9 & ISO14971) and Lifecycle Compliance
Benefit:
Streamlined development and compliance, reducing delays and ensuring safe, effective products.
Expertise Across The Lifecycle
In each of these sectors, we support products through their full lifecycle, including:
- Regulatory Submissions and Market Authorization: Expertise in FDA, EMA, and global pathways for timely product approvals.
- Quality Management and Audit Readiness: Customized QMS development and support to meet global standards and regulatory expectations.
- Risk Management and Compliance: Proactive risk frameworks and CAPA management to ensure sustained product quality and safety.
Ready to Partner?
Precision Regulatory Consulting LLC is committed to helping your company achieve regulatory success in an increasingly competitive market.
Contact Us today to learn how our industry expertise can support your compliance and quality goals.
“Leonel’s guidance has been invaluable in securing market approvals and achieving 95% compliance across our global facilities.”
Director of Quality Assurance
Biopharma Company
Previous Clients
What Our Clients Say in Linkedin
Leo continually demonstrates the absolute best attributes of a true leader and manager. His ability to quickly assess and implement optimization, while earning the trust of his colleagues, makes him a solid asset to any team and organization
“Leonel has been one of our Injectables and Combination Products communities advocate and pioneer. It’s always a pleasure to collaborate with Leonel as he’s been highly regarded as a subject matter expert in this field, with deep understanding on product lifecycle and quality management in a global setting! “
“Leonel delivered on every milestone and more. His passion for developing others was evident in some key training that he designed and delivered: training on design controls, human factors, risk management, and US/CAN/EU MDR evolving regulations. He was the go-to subject matter expert to consult with when device questions arise, even from other SMEs.”
Follow us on