Contact
Three ways to start. None of them requires a document.
Book a complimentary 30-minute scoping call, send a project enquiry, or request a fixed-scope technical assessment. You will hear back from the consultant within one working day. Confidential files never travel through this page.
1 · Book a scoping call
Book a 30-minute scoping call
Complimentary, for scoping and fit. The call does not provide device-specific regulatory advice; that begins with a written scope. Times are shown in your own time zone.
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2 · Send a project enquiry
3 · Request a technical assessment
A defined, paid piece of work with a stated scope, inputs, output, exclusions and timeline, quoted after a short call. Nine fixed-scope offers exist; the most common are below. Each is a first deliverable, not the full project it prepares for.
- Classification and pathway memo — 10 working days
- Technical documentation gap report (MDR/IVDR Annex II/III and GSPRs) — 15 working days
- FDA pathway and QMSR readiness assessment — 15 working days
- CDSCO licensing route map — 10 working days
- QMS gap assessment (ISO 13485, QMSR or MDSAP) — 15 working days
- Biological evaluation plan and TRA scope — 10 working days
- Toxicological risk assessment (ISO 10993-17:2023) — 20 to 30 working days by compound count
- Integrated SaMD regulatory plan — 15 working days
- IVDR classification memo and PEP outline — 15 working days
Use the enquiry form above and name the assessment in the message, or email contact@authentcare.com.
4 · Secure document exchange
Confidential documents never travel through this website or as email attachments. After the first conversation you receive a "Specific people" upload link to a folder created for you on Authentcare's Microsoft 365 tenant. The link is tied to your email address, verified with a one-time passcode, limited to that folder, expires after 30 days and is revoked at project close. No "anyone" links exist on the tenant.
A mutual non-disclosure agreement is available on request before any document is shared. Read how client documents are handled in the privacy notice.
Practicalities
- Telephone
- +91‑9873118957
- Time zone
- IST (UTC+5:30); calls arranged to suit yours
- Response
- A personal reply within one working day; a written scope within three working days of a scoping call
- Registered office
- Authentcare Private Limited, 307, Pragati Tower, Rajendra Place, New Delhi 110008, India