Frequently Asked Questions

FAQ's about our Free Regulatory Review

• What exactly is included in the free regulatory and risk assessment? 

  • ​You will receive the following:​

    • predicted regulatory approach for your product based on its predicted indication and delivery mechanism (implant, wearable, oral, injection, etc.)​

    • Likely regulatory pathway for your product (fast track, EUA, HUD/HDE, 510(k), de novo, PMA, BDD, STEP, etc.)

    • Likely risks, such as manufacturing, regulatory, legal risks, etc.

    • Median time to market based on similar products/pathways/risks

• How detailed is the free assessment?

  • the free assessment is a high level overview of your innovation's regulatory pathway. think of it as a general regulatory checkup.​

• What kind of risks are assessed? 

  • Manufacturing, regulatory, and legal risks, just to name a few​

• What happens after the free assessment?

  • Our free assessment has no strings attached. We send you our assessment via email​ and let you know about our premium RA/QA/CA monthly subscription option if you need additional support. 

• How long does it really take to get the assessment? 

  • Once we receive your name and email submission through the website, we send you a quick for mto fill out (includes a mutual NDA and confidentiality agreement to protect your IP) and once we receive that form filled out and completed, we will finish your free review within 48 hours.​

• Is the free assessment really free? 

  • There are no hidden costs. We do not ask for a card on file like some other 'free' trials do. We are offering the ONLY (to our knowledge) 100% free regulatory review out there.​​​

• What if I have follow-up questions about the free assessment?

  • We encourage you to become a premium subscriber for ongoing RA/QA/CA help. ​

• How do I know my information is protected?

  • WelsfordAI has been in the RA/QA/CA consulting business for decades, and has a proven track record of helping clients. We have a mutual NDA and confidentiality agreement to protect your IP. However, if your company's legal team has a different NDA or form they would like us to review, please let us know, and we will accommodate as much as is reasonably possible.​

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FAQ's About the Monthly Premium RA/QA/CA Subscription:

• What is included in the monthly subscription? 

  • This is individually tailored to your company/innovation and individual needs. The first thing we will do once you sign up is schedule our initial meeting. In this meeting we will understand your product/innovation, your company or startup, and your goals. After the meeting you will receive a detailed work plan with deliverables that are matched to where you are in the product lifecycle, and what RA/QA/CA work has been completed up to this point.​

• What kind of regulatory documentation is provided? 

• • estimated time to market based on your specific product

  • project management deliverables (GANTT, Schedules, Resource breakdowns, etc.)

  • QMS documentation including DHF/master file components, procedures, and forms

  • Full submission drafts (eStar and eCTD formats, etc.)

  • We also can help with business planning, market research, branding, etc., just let us know what your company needs!

• This depends on where your innovation is at in the product lifecycle, but can include:

  risk management documentation (FMEAs, REMs, etc.)​

• How often is the documentation delivered?

  • After your initial meeting, you will receive a work plan with deliverables and estimated delivery dates. ​

• Can I cancel my subscription at any time? 

  • Yes, you can. Please contact us through our contact form on the website, or contact the project manager assigned to your account for help canceling.​

• How do I access the detailed regulatory documentation? 

  • Deliverables will be mainly shared via email, however we are happy to accommodate the platforms that your company uses such as Slack, Teams, etc. just let us know!​

• Is there a limit to the number of documents I can access?

  • There is not a 'limit' per say, but we will work with you to determine the deliverables that are needed for where your company or innovation is at in the product lifecycle.​

• What if I need help understanding the documentation?

  • We are happy to provide clarification over email or in a followup meeting to help explain. ​

• Are there discounts for longer subscriptions?

  • We are working on a referral discount and other discounts and coupons- check back for more information soon!​