Our Company

What you should know about us

Mittal Consulting empowers medical device manufacturers from all over the world with seamless regulatory consulting services. Through our highly trained best in the business writers and ex-FDA consultants, we offer recognized expertise in assisting medical device companies with cost-effective regulatory pathways to achieve long-term product success. We also have a vast and trusted network of references to other specialties for companies looking to break into US or EU market. With proven proficiency in handling all classes of US FDA and EU device submissions, Mittal Consulting specializes in

 

  • Regulatory Strategy Reports (VC friendly)
  • 510(k) submissions to FDA
  • Q-sub or Pre-sub prep and Submissions
  • Class III PMA submissions to FDA
  • EU-MDR Submissions and support
  • Post Market Support
  • Integrate Marketing and Reimbursement for product success

To me business is about understanding the mindset of a company and providing innovative solutions to its problems. I am always willing to do something I am not ready to do, and that is how I grow. We take calculated risks on our end to provide our clients with the most seamless submission experience ever in the regulatory industry.
Kristen Mittal RAC, PMPCo-founder and CEO, Mittal Consulting

Our Team

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Affiliate Consultants

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OUR MISSION, VISION & VALUES

How We Work

Mittal Consulting’s unique expertise provide support options where you require it the most. We will meet you at the level of assistant required throughout your product journey.

TIER 1 HOURLY SUPPORT

  • Submission Advice for Your Team
  • Assist Internal Project Teams
  • Continue from Previous Projects or Submissions

TIER 2 PROJECT BASED SUPPORT

  • Complete Regulatory Submissions
  • Connect You with Our Partners for Additional Services
  • Project / Duration-based Quote

TIER 3 RETAINER SERVICES

  • Set Fee Monthly Retainer Services
  • Unlimited Consultation as per Terms of the Retainer
  • Best for Early-Stage Companies Who are Pre-Commercialization