About DK Reg Compliance — India’s Drug Regulatory Consultants
Practical, process-oriented regulatory expertise for the Indian market.
Connect with our senior regulatory experts in 15 mins.
Why DK Reg Exists
Most businesses that fail regulatory approval in India don’t fail because their product is unsafe or non-compliant — they fail because of avoidable errors in the process: wrong license type applied for, incomplete documentation, incorrect premises layout, or a deficiency response that came in a day late. Every delay costs money. Every rejection resets the clock.
DK Reg Compliance was built to close that gap — providing regulatory expertise that is practical, process-oriented, and specific to the Indian regulatory environment, not generic advice copied from a global template.
We are a drug regulatory consultancy handling the full spectrum of Indian pharmaceutical, medical device, food, and cosmetic compliance:
retail, wholesale, manufacturing, and loan licenses with State FDA authorities across India
medical devices (Class A–D), IVDs, new drugs, fixed-dose combinations, and cosmetic import registration via the SUGAM portal
basic registration, state license, and central license for food businesses via FoSCoS, including nutraceutical and FSMP compliance
MD-14 applications and MD-15 import licenses, Device Master File and Plant Master File preparation
manufacturing licenses (State FDA) and import registration (CDSCO) for beauty and personal care brands
We start with classification — identifying exactly which authority, which license type, and which process applies to your product and business model before any documentation work begins. This one step prevents the most common cause of application delays: misclassification.
Once the pathway is confirmed, we prepare state-specific (not generic) documentation, file on the correct portal, and actively manage queries and deficiency notices within the authority’s stipulated deadlines. We do not hand you a checklist and leave you to figure out the rest.
DK Reg Compliance is headquartered in E-29, Aligarh, Uttar Pradesh, and serves clients across India — from pharmacy owners in Delhi NCR, Mumbai, Bengaluru, and Hyderabad to foreign medical device manufacturers entering the Indian market for the first time.
Our clients contact us by phone, WhatsApp, or email — we are reachable, responsive, and provide a dedicated regulatory associate for each active engagement.
The wrong license type or a misclassified product wastes months. We confirm the pathway before the paperwork.
You know what stage your application is at, what was submitted, and what is expected next — at every point in the process.
State FDA query deadlines and CDSCO’s 30-day deficiency windows are hard cutoffs. We respond within 24–48 hours of query receipt, every time.
We do not promise timelines we cannot control or outcomes we cannot guarantee. We tell you what is realistic, what the risks are, and what we need from you to give your application the best possible chance.
Frequently Asked Questions
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Call +91 9084706423 or WhatsApp for a consultation.