We provide pharmaceutical regulatory consultants.
1preparation of registration dossiers for submission to various regulatory agencies all over the world (ectd, ctd, actd format & country specific requirements).

drug master file (dmf) preparation & compilation for open and closed part.

preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.

expert reports on quality , pre-clinical and clinical

orphan drug application preparation and submission.

prepare summary of product characteristic (smpc), pack insert, product rationale.

assistance in response to queries for submission to the regulatory agencies.

total development of product from lab scale to pilot plant scale to actual production scale for drug substance and drug product.

prepare summary of product characteristic (smpc), pack insert, product rationale.

periodic safety update report (psur) preparation.

provide analytical support in analytical method development / validation, routine analyses of products by hplc/gc/ms etc.

complete stability programme management service is provided as per ich guidelines/special requirements in a cgmp and glp compliant environment.

monitoring and liaisoning with the cros for clinical and be studies.

preparation of site master file

We provide pharmaceutical regulatory consultants.
Product approval: new product approval, existing product approval.
Registration/licensing: conversion of existing license into fssai, renewal of registration/license, fresh registration/license
so avail our services for.obtaining fssai registration / license of proprietary food, dietary supplement & nutraceuticals