Services
Precision Regulatory Consulting LLC specializes in providing regulatory affairs and quality management expertise to support the biotech, pharmaceutical, and medical device industries. Led by Leonel “Leo” Vanegas, our services are designed to help you navigate complex regulatory landscapes, optimize quality systems, and ensure successful product launches.
Offerings
Regulatory Strategy & Compliance
Service Overview:
We offer end-to-end regulatory strategy consulting, helping companies align with global standards and expedite approvals.
• Regulatory Submissions: INDs, NDAs, BLAs, and 510(k)s, tailored to FDA and EMA requirements for drugs, biologics, and combination products.
• Compliance Frameworks: Customized approaches for meeting FDA, ISO, and EU MDR compliance, reducing the risk of delays and costly rework.
• Market Authorization Strategy: From pre-submission meetings to post-market surveillance, we help your product move through every phase of regulatory approval smoothly.
Quality Management Systems (QMS) & Audit Readiness
Service Overview:
Our quality management services ensure your systems meet global regulatory standards, preparing you for successful audits and market entry.
• QMS Development & Optimization: We create robust quality systems or enhance your current QMS to align with ISO13485, FDA, and MDR requirements.
• Audit Preparation and Support: Includes gap assessments, audit readiness training, and on-site or remote audit support.
• Risk Management and CAPA: Proactive risk management frameworks and Corrective and Preventive Actions (CAPA) that reduce compliance risks and support continual improvement.
Ideal for: Organizations needing a strong foundation in quality management to increase compliance and reduce operational risks.
Product Development & Lifecycle Management
Service Overview:
Precision Regulatory Consulting provides comprehensive support across the product lifecycle, from initial development to post-market surveillance.
• Design Control and Validation: Expertise in design control requirements, method validation, and documentation to meet FDA and EU standards.
• Lifecycle Management: Ongoing quality oversight, document management, and change control support to maintain product compliance.
• Combination Products & Biologics: Specialized support for complex products requiring both drug and device compliance, ensuring seamless regulatory alignment.
Ideal for: Teams looking to optimize their product lifecycle management and maintain regulatory compliance from development through commercialization.
Training & Mentorship
Service Overview:
We offer personalized training to build regulatory and quality expertise within your team, equipping them to handle regulatory challenges confidently.
• Audit Readiness Training: Programs designed to enhance your team’s readiness for inspections and ensure a culture of compliance.
• Quality Systems Training: Tailored training on CAPA, risk management, and QMS best practices.
• Mentorship Programs: For emerging leaders and teams, Leo provides guidance on navigating complex regulatory landscapes and instilling a quality-focused mindset.
Ideal for: Companies aiming to foster internal expertise in regulatory and quality management.
Partner With Us
Whether you’re navigating your first submission or optimizing a mature quality system, Precision Regulatory Consulting LLC is here to help you achieve regulatory success and bring high-quality products to the market. Contact us today to discuss how we can support your goals.