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Clinical research · Regulatory support · India and USA

Contact REGHELPS SRC

Talk to our clinical and regulatory team about PMCF studies, clinical investigations, usability studies, IVD performance studies, CE marking, FDA submissions or your quality system. Tell us about your device and we will suggest the right next step.

Send us a message Find our offices
4offices in India and the USA
1 daytarget reply time
Freeinitial consultation
NDAavailable before you share details
Quick contact

How would you like to get in touch?

✎
Request a proposalUse the form below for a study or service quote.
@
Email usinfo@reghelps.com
IN
Call India+91 97058 35637
US
Call USA+1 763 352 4174
What happens next

From your enquiry to project kick-off

A simple, transparent process with no obligation until you approve a proposal.

Send your enquiryShare your device, markets, service and timelines.
ConfidentialityWe sign an NDA if you need one before details are shared.
Discovery callA free call with the right specialist to understand your needs.
ProposalA clear scope, timeline and budget for your approval.
Kick-offA dedicated project lead and a start date agreed with you.

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Our offices

REGHELPS offices in India and the USA

Head office

Bengaluru, India

RegHelps SRC Private Limited
#303, Shakthi Mansion, 2nd Block
Ramamurthy Nagar, Bengaluru 560016
Karnataka, India
+91 97058 35637+91 70190 31781Get directions →
Marketing office

Bengaluru, India

#1383, 5th Block, HBR Layout
Outer Ring Road, Bengaluru 560043
Karnataka, India
+91 97058 35637+91 70190 31781Get directions →
Marketing office

Delhi, India

51A, Pratap Nagar, Gali No 2
Mayur Vihar, Delhi 110091
India
+91 97058 35637Get directions →
USA office

North Carolina, USA

Regseek LLC
Emeline Way, Fuquay-Varina
NC 27526, USA
+1 763 352 4174Get directions →
Our services

What can we help you with?

PMCF Studies Clinical Investigation Human Factors and Usability Studies IVD Performance Studies EU MDR CE Marking CE Marking for IVD Devices 510(k) Premarket Notification Medical Device QMS Consultants European Authorised Representative
FAQ

Contact FAQs

How quickly will REGHELPS reply to my enquiry?

We aim to reply to every enquiry within one business day. For urgent regulatory deadlines, mention the date in your message or call us directly.

Can we sign an NDA before sharing device details?

Yes. We are happy to sign a confidentiality agreement before you share technical, clinical or commercial information about your device.

Which countries and markets do you support?

We support manufacturers worldwide from our offices in India and the USA, with services covering the EU MDR and IVDR, US FDA, UK MHRA and India CDSCO requirements.

What should I include in my message?

Your device or IVD, its intended purpose and risk class if known, your target markets, the service you need and any deadlines. This helps us send an accurate proposal faster.

Do you offer a free initial consultation?

Yes. Your first discussion with our team is free, and we can usually suggest the right approach, such as a study design or regulatory route, before you commit.

Can I request a quote for a single service?

Yes. You can request a quote for one service, such as a PMCF study or a technical file review, or for a complete programme from clinical evidence to market approval.