Skip to content

Master FDA Compliance with Precision

Navigate the complexities of FDA regulations with our expert guidance and ensure your products meet all compliance standards.

Start Your Compliance Review
Regulatory Expertise

Comprehensive FDA Compliance Services

Navigate the intricate landscape of FDA compliance with our specialized services. From initial product conception to market launch, we ensure your operations meet all FDA regulatory requirements. Our comprehensive support covers everything from establishment and device registrations to complex risk management planning, helping you mitigate compliance risks and accelerate your market entry. Whether you're dealing with medical devices, cosmetics, or food products, we provide the expert guidance needed to navigate these regulations successfully.

Learn More
medical pills industry factory and production indoor-1

Our Services

Establishment Registrations

We assist with the FDA registration of establishments involved in the manufacture, processing, packing, or storage of drug and food products, ensuring compliance with federal regulations.

Cosmetic Registrations

Our services include guiding companies through the FDA regulatory process for cosmetics, ensuring all products meet safety and labeling requirements before they hit the market.

Medical Device Registrations

We help with the FDA registration process for medical devices, including preparing and submitting the necessary documentation for 510k clearance or PMA approvals.

Food Facility Registrations

Our team ensures that your food facilities are registered with the FDA, complying with the latest food safety regulations to prevent any legal or operational disruptions.

Labeling Compliance

Our experts ensure your product labels meet FDA standards, covering everything from ingredient listings to nutritional information and usage instructions.

Import/Export Compliance

We assist with the FDA compliance for importing and exporting products, including managing prior notices for shipments, ensuring smooth and compliant international trade.

Partnership and Trust

Join Our Successful Clients

Become part of a distinguished group of companies that have successfully navigated FDA regulations with our help. Our clients range from startups to large corporations across various industries, including medical devices, cosmetics, and food production. By partnering with us, they have not only achieved compliance but have also enhanced their market presence and operational efficiency. Join our successful clients and experience the peace of mind that comes from knowing your regulatory needs are expertly handled.

Start Your Compliance Journey
Working woman at automated production line in modern factory

Why Choose Us

Choose our services for unmatched expertise in FDA compliance. With a deep understanding of FDA regulations and a proven track record of success, we excel in navigating the complex regulatory landscape. Our team of experts is committed to providing personalized support, ensuring that your products not only meet but exceed all regulatory standards. We specialize in turning compliance challenges into opportunities for growth, ensuring that your business thrives in a regulated environment. Trust us to be your guide in achieving and maintaining FDA compliance.

Contact Us

(205) 536-9016
sales@cytogence.com
M-F 9AM-6PM

AL Office

505 20th St. N.
Suite 1220 1485
Birmingham, AL 35203

Japan

0774-30-9579
sales@cytogence.jp
Kyoto, JAPAN