Health Canada & FDA Regulatory Consulting | Arora 297 Consultancy

Free 30-Minute Call

Walk Away With a Clear Regulatory Roadmap

Most companies lose months — and thousands of dollars — trying to figure out regulatory requirements on their own. One 30-minute call with a senior expert changes that.

✓
Know exactly what's required
No more guessing which pathway, which forms, or which agency.
✓
Get a realistic timeline
Know when you can realistically launch and what can slow you down.
✓
Avoid costly mistakes
A wrong first step can delay your launch by 6–12 months. We prevent that.

What We Do

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We believe in mutual growth
Rely On Our Experts For Regulatory Matters

Being active in the industry from the past two decades, we are aware of its complexities and challenges. We assist you to find the best possible solution for your problem keeping in mind the legalities and compliance associated.

Arora 297 consultancy specializes in US FDA, Health Canada, EU and other countries regulatory compliance matters. We provide best-in-industry consultancy and assistance to firms dealing in the medical device, drug, cosmetics, diagnostic kits, biologics and food for compliance with US & Canada regulations and guidelines.

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Global Regulatory Services

  • 01
    Strategy Planning
  • 02
    PRE Submission
  • 03
    Submission/Registration
  • 04
    Post Submission/Approval
We offer the following solutions

Featured Services

We have 20 years of Experienced in Trusted Regulatory Services

REGULATORY

From ingredient compliance checks, label compliance, regulatory submissions, life cycle management of NHP, drugs, cosmetics and medical devices, and all complimentary services around the product.
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STRATEGIC ADVICE


From strategic product development, formulation support, gap analysis, market research report, and data analysis.
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COMPLIANCE AND QUALITY


Establishment License, Site License, Import/Export, eCTD, CTA, DMF, Publishing, GMP, GLP guidelines, SOP development and more
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POST APPROVAL


Post Marketing Surveillance programs, Risk Management Plan, Pharmacovigilance reporting and support
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EDUCATION, TRAINING & CONSULTING SERVICES

Training services to individuals, organizations and institutions in person and via electronic medium; to enable a practical understanding of the Global regulatory process and updates. We offer both custom and standard training sessions. Learn more about some of the education modules by checking our Knowledge page.
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  • “Great experience with Arora 297 Consultancy. Very helpful, knowledgeable, professional and affordable. Look forward to working with Avinash again very soon! ”

    REVIEW 8 X AMAZON PRODUCT LISTINGS FOR PROBLEMATIC MARKETING CLAIMS

  • “ Excellent, will work with again. Prompt delivery, knowledgeable, and was willing to speak by phone to answer questions. Will be in touch again soon.”

    REVIEW FDA INGREDIENT SUBMISSION

  • “ Very happy to have found Avinash when we did. When I found him, we were in a bind and needed a lot of applications to be submitted to Health Canada. As we got started, I was impressed with his professionalism when he asked me, the client, to create an NDA. ”

    NHP SUBMISSIONS 20 + PRODUCTS BOTANIC RESEARCH USA
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