REGULATORY SERVICES

We offer a wide range of services to support your regulatory needs, including:

• Project Management for Regulatory Submissions: Management of INDs, IDEs, 510(k)s, BLAs, and NDAs, ensuring timely and successful submissions.
• Process Improvement and Corrective Actions: Implementing process improvement initiatives and corrective actions to optimize your regulatory operations.
• Training and Coaching: Providing training and coaching for regulatory teams to enhance their knowledge and skills.
• Supplier Audits: Conducting supplier audits to ensure compliance with regulatory requirements.
• Premarket and Post-market Regulatory Meetings: Facilitating meetings with regulatory agencies to address enforcement actions and improve communications.

  Our team of consultants is here to support our domestic and global customers with:

* Registration Management & Device Listing: Streamline your mandatory FDA filings with ease.

* Designated US Agent: Act as your representative to meet US operational requirements.

* UDI / GUDID Setup & Submissions: Simplify the process of unique device identification and database entries.

* Device Classification Assistance: Help you accurately identify the FDA Class for your medical device.

Regulatory Strategy and Compliance: Expert guidance on navigating FDA regulations (CFRs) and standards, including QSR, ISO 13485, and 21 CFR 820.

Our expertise are as follows:

 Strategic Planning & Execution

• Scientific Research
• IT Project Management
• IVD Medical Device and Drug Regulations
• Customer Education, Training & Presentations
• Policy & Procedure Development
• Regulatory & Standards Compliance
• Process Improvement Initiatives and Corrective Actions
• Supplier Audits
• Knowledge of INDs, IDEs, 510ks, BLAs, NDAs & Enforcement Actions
• Technical Support/Data Analysis
• High Impact Presentations
• Cross-Functional Teams
• Staff Development & Leadership
• Premarket and Post-market Regulatory Meetings (i.e., Pre-Sub meetings)
• FOIA requests, registrations, archival research

Post-Market Surveillance Plan Development: Understanding regulatory requirements allows companies to set up efficient post-market surveillance systems from the outset. Early planning for these activities can ensure faster resolution of safety concerns and maintain market presence.

RegQ Consulting helps organizations implement sustainable practices that reduce environmental impact while enhancing brand reputation. Join us in making a positive difference while achieving your business objectives.

Experience in drug regulations empowers professionals to train and mentor teams within the organization, fostering a culture of compliance and continuous improvement.