Regulatory Challenges?
We Have the Solution.

We provide a multitude of regulatory compliance solutions for our clients across a range of FDA regulated industries.

What We Do

Regulatory Strategy

Regulatory Strategy Consulting

We’ll put you on the path of success, helping to avoid potential obstacles and get you to market faster.

Regulatory Submissions

Regulatory Submissions

From pathway identification to application submission, we offer turnkey solutions for your FDA regulatory submissions.

cGMP

cGMP Compliance

We’ll help you achieve regulatory compliance for your facility through audit preparation, procedure development, live audit support, and more.

Regulatory Publishing

Regulatory Publishing

Let our in-house technical writing team manage document development, compilation, formatting, and eCTD compliance needs for your project.

Postmarket Support

Post-Market Support

Our services extend beyond market acceptance. Our team handles warning and deficiency letters, post market surveillance, and more.

Clinical and Nonclinical Studies

Clinical & Non-Clinical Studies

With our global network of industry experts and CRO’s, we have the right people at the right time to address your project’s unique needs.

Who We Are

At Accorto Regulatory Solutions, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market and work with providers of FDA regulated products and services to ensure they are operating in a compliant manner.

Industries We
Serve

We’ve worked to perfect our processes and develop bespoke regulatory compliance solutions for a range of FDA regulated industries. Our specialties include:

Medical Devices

Medical Devices

Pharmaceuticals

Pharmaceuticals

Cosmetics

Cosmetics

Nicotine

Harm Reduction Products

The FDA Doesn’t Wait.
Neither Do We.

Whether you are working to get your product on the market, currently in the application process, or managing post-market reporting requirements, we know every second counts. At Accorto, we thrive on delivering swift and adaptable solutions tailored to our clients’ unique needs.

Facing a time-sensitive project that needs immediate attention?
Count on us to deliver rapid, same-day responses to all critical inquiries,
ensuring your goals are met without delay.

speed flexibility personalization resources expertise connections

Why Choose Us

Our team offers the best of both worlds in the regulatory consulting industry.

Without the bureaucracy and red tape you would get with a large agency, our team is able to provide custom tailored solutions to save our clients time and money on every project. And with an in-house team of industry experts and a network of some of the nation’s leading CRO’s on speed dial, we always have the resources to solve your regulatory challenges quickly and effectively.