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RegQ Consulting LLC is a project mangement firm which can help you overcome regulatory hurdles that can make or break your projects in the complex world of medical devices and pharmaceuticals. RegQ Consulting brings over 14 years of experience navigating these challenges, ensuring your submissions are not just compliant but successful. From FDA regulations to innovative technologies, RegQ Consulting experts provide project management services to keep you ahead of the curve.
Ready to achieve regulatory excellence?
Are you seeking a strategic partner to guide your medical device or pharmaceutical project through the intricate regulatory landscape? At RegQ Consulting we are seasoned regulatory affairs and public health leader passionate about fostering collaboration between scientific and regulatory communities. With a deep understanding of FDA regulations and a proven track record of success, she empowers cross-functional teams to deliver exceptional outcomes.
Let's build a compliant future, together.
In the fast-paced world of medical device and pharmaceutical innovation, staying ahead of regulatory changes is crucial. RegQ Consulting combines her extensive experience with FDA regulations, project management expertise, and a passion for driving innovative technologies to provide tailored solutions for your regulatory needs. She has a proven track record within the FDA and industry.
Transform your regulatory challenges into opportunities.
With over 14 years of experience in regulatory affairs and public health at FDA, RegQ Consulting delivers excellent outcomes for medical device and pharmaceutical companies seeking regulatory compliance and project management support. From FDA submissions to process improvement, she provides the leadership and expertise you need.
At RegQ Consulting, we are FDA trained project consultants knowledgeable in FDA regulations, Class I and ClassII devices, 510(k)s and IDE's and
*We are excellent facilitators and experts at managing FDA Presubmission meetings.
*Management of your 510k submissions
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.
RegQ Consulting offers services to contributes *to the development and maintenance of quality management systems that adhere to industry standards standards
* Development of operating procedures (SOPs), leading to improved product quality and safety.comprehensive
*rRisk management & corrective actions (CAPA) services to help you:
*Identify, assess, and mitigate potential risks.
*Respond to enforcement actions and warning letters.
*Internal Audits ensures that your business is well-prepared to face challenges regulatory challenges
We
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.
Embracing sustainability is not only good for the planet, but it's also good for business. 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.
Our mission is to empower businesses to reach their full potential by providing Regulatory Project Management expertise, guidance and innovative solutions. We are committed to helping our clients navigate the complexities of the regulatory environment to achieve market success
At RegQ Consulting, we believe in integrity, excellence, and collaboration. We are dedicated to building strong relationships with our clients and delivering exceptional service that exceeds their expectations.
We offer a wide range of business and management consulting services, including strategic planning, financial analysis, market research, and more. Our team of experts has the knowledge and experience to help you achieve your goals.
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