As a boutique firm, we provide personalized, red-tape-free service with direct access to our full-time team of over 18 in-house, experienced consultants. Our team delivers faster response times, customized solutions, and flexible support tailored to your company’s size and needs.
We work with small to mid-sized domestic and international companies in FDA-regulated industries, including medical devices, pharmaceuticals, cosmetics, and nicotine products.
We handle a wide range of submissions, including pre-submissions, 510(k), De Novo, PMA, IND, NDA, EUA, PMTA, Establishment Registration & Device Listings, and more. We also support post-market requirements and compliance audits.
Yes. We are industry leaders in PMTA submissions, having filed over 800 traditional and synthetic nicotine products. Our applications remain among the small fraction still under FDA review without denial orders.
Absolutely. We offer tiered Regulatory Due Diligence packages designed to give startups and investors confidence before making critical business or investment decisions.
Yes. Through our strategic alliance with Inter Scientific, we provide integrated regulatory and analytical testing services across the U.S., Europe, the Middle East, and Asia.
Our consultants support cGMP compliance, audit preparation, and gap assessments. We also provide guidance on corrective and preventive actions (CAPA) to keep your operations FDA-compliant.
Simply contact us through our website (accortoreg.com) to schedule a consultation. We’ll assess your needs and recommend a tailored plan to help you navigate regulatory challenges efficiently.
Filing a Premarket Tobacco Product Application (PMTA) requires detailed product chemistry, toxicology, clinical, and marketing data. The FDA evaluates whether the product is appropriate for the protection of public health. Accorto Regulatory Solutions has successfully submitted PMTAs for over 800 traditional and synthetic nicotine products, guiding clients from data collection through submission and ongoing FDA communication.
A 510(k) submission must demonstrate that your medical device is substantially equivalent to a legally marketed device. This typically includes device descriptions, performance data, labeling, and sometimes clinical data. Accorto’s experts prepare and publish 510(k) files that meet FDA requirements, helping clients avoid costly delays.
A 510(k) is for devices that can show substantial equivalence to existing products that have already been approved by the FDA and are legally marketed in the US. De Novo is for novel devices with low to moderate risk where no predicate exists. PMA (Premarket Approval) is for high-risk devices that require robust clinical evidence. Accorto guides clients in choosing the correct pathway and prepares complete submissions for each.
Following submission, PMA approval can take 180 days or more, depending on the completeness of the application and FDA review cycles. Delays often occur due to data gaps. Accorto provides strategic planning, clinical trial coordination, and technical publishing to help streamline the process.
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to U.S. cosmetic regulations in decades. It requires manufacturers to register facilities, list products, report adverse events, and maintain safety documentation. Accorto assists cosmetic companies in meeting these new compliance obligations.
Current Good Manufacturing Practice (cGMP) regulations are standards for manufacturing, testing, and quality assurance to ensure product safety and consistency. Non-compliance can result in warning letters or shutdowns. Accorto conducts mock audits, prepares facilities for inspections, and advises on CAPA (Corrective and Preventive Actions).
Investors typically request a regulatory due diligence review, which assesses submissions, compliance history, and product readiness. Accorto offers tiered due diligence packages tailored to investor needs, providing a clear compliance snapshot before financial commitments.
An Investigational New Drug (IND) application must include preclinical study results, manufacturing details, and clinical trial protocols. This ensures subject safety before human trials begin. Accorto helps pharmaceutical and biotech companies prepare, review, and submit INDs efficiently.
Preparation includes conducting internal audits, reviewing SOPs, training staff, and ensuring documentation is complete and accessible. Accorto provides mock audits, gap analyses, and hands-on support to minimize risk and ensure readiness when FDA inspectors arrive.
Most PMTAs fail due to incomplete scientific data, inadequate toxicology reports, or poor alignment with FDA expectations. Accorto’s proven expertise and strategically developed PMTA submissions give clients an edge, ensuring robust applications with a much higher chance of FDA acceptance.
