POST APPROVAL CHANGES for medical devices

Get authorized agent support for all your post approval changes to Medical Device substance for already approved Medical Device manufacturing site

Model Approval in India

At CliniExperts, we ensure that your approval does not extend while you work on launching your product in the market.

Permission to Manufacture Class C & D In- Vitro Diagnostics

Cliniexperts provides you with a one-stop solution for your IVD products needs right from test or Manufacture licenses to manufacturing and post-marketing licenses.

Permission to Manufacture Class C & D Medical Devices

CliniExperts can functions as authorized agent in India. It has a firm position in the Indian Healthcare market, and holds a valid Drug Wholesale License.

POST APPROVAL CHANGES For Drugs

Get authorized agent support for all your post approval changes to drug substance for already approved drugs or drug manufacturing site.

POST APPROVAL CHANGES For Biologicals

Get authorized agent support for all your post approval changes to biological substance for already approved biologicals manufacturing site

Test license to manufacture In Vitro Diagnostics in India – MD 12 & MD 13

Registration for in-vitro diagnostic medical devices for manufacturing can be time-consuming and tedious

Permission to Manufacture Class A-B Medical Devices in India – Form MD 3 & MD 5

The application for manufacturing, sale or distribution of any medical device includes a tedious list of processes and forms

COSMETIC LABEL COMPLIANCE

CliniExperts regulatory advisers help to evaluate all aspects from legal to regulatory compliances for Cosmetic to meet all the requirements in the form directives, regulations and standards stated by CDSCO.

SUGAM Registration- MD/ IVD in India

We at CliniExperts, make sure that our expert team creates your registration easy and quick so that you can focus on more important aspects of your product launch.

IN-VITRO DIAGNOSTIC KITS LABEL COMPLIANCE

At CliniExperts, our teams constantly update their knowledge concerning the changes and new guidelines to make your process easy and correction-free

MEDICAL DEVICE LABEL COMPLIANCE

Manufacturers/importers often find it difficult to keep track of all the requirements. At CliniExperts, we ensure that your medical device labels comply with the guidelines and regulations laid down by the CDSCO.