Secure Your Investment
Our team of seasoned regulatory experts provides various levels of review and support for your regulatory strategy, increasing the likelihood of application acceptance and expediting the path to market. If gaps are identified, we not only pinpoint the issues but work directly with your team to develop tailored solutions, ensuring your project stays on track for FDA compliance and approval, while helping to mitigate risks and avoid costly delays.
For Investors
Our program offers an in-depth analysis of potential investments, ensuring the company you back has a robust regulatory strategy and a clear path to market.
For Startups
Our service provides the validation needed to confirm your regulatory plan, empowering you to present a solid case to investors and secure the funding essential for your innovation’s success.
Programs Unique to Your Project Needs
We understand that every project has distinct needs and requires different levels of support, which can make planning difficult. To help you get started, we’ve outlined our three most popular support tiers below:
Basic
Already have a regulatory strategy in place? Let us validate your application strategy and processes, giving investors the confidence they need to move forward with their investment.
Starting at $10,000
Standard
Looking for additional support? Our Standard package provides additional peace of mind. Our team will work with you to build a custom regulatory strategy and verify this strategy with the FDA, giving you 100% confidence in achieving market acceptance. This package includes everything from the basic package with the addition of:
Starting at $20,000
Premium
Consider Accorto your on-call regulatory team. Our premium service package offers complete turnkey regulatory support, including document creation, data summarization, and project management. In addition to all services listed in our Basic and Standard packages, our premium service also offers:
Starting at $40,000
Customized Support
If a full support package isn’t what you’re looking for, Accorto offers flexible, targeted assistance. All of our regulatory due diligence services are available on an à la carte basis, allowing you to select the specific support you need. These services can also be seamlessly integrated into any of our support packages for a tailored solution that fits your requirements.
- Review the product and confirm the likely proper classification
- Predicate Review and Verification
- Regulatory Pathway confirmation (510k, PMA, De Novo, Etc.)
- Design History Review
- Cybersecurity Review
- Review of Existing Data for Compliance and Usability
- Confirmation of Non-clinical and Clinical Testing Requirements
- Claims Substantiation and Packaging/Labeling Review
- Review of 21 CFR 820 / cGMP Requirements for Manufacturing
- Assessment of Opportunities for Breakthrough Device Designation (BDD) or Safer Technologies Program (STEP)
- Verify Strategy Through FDA Q-Submission
- Formal Risk Assessment Document
- Full Budget and Project Timeline from Vetted CROs
- Reimbursement Assessment and Strategy
- For Connected Devices: Secure Medical Device Software Development Attestation (Required for any medical device firm seeking to sell to the Veterans Health Administration)
- Conference Calls between Startups and Investors as Requested
