At the heart of everything we do is regulatory affairs. We understand our clients’ need for their products' route to market to be as smooth as possible.
This requires us to have relevant regulatory knowledge at our fingertips, so that we can advise on the optimum regulatory pathway to follow, and ensure that your technical documentation conforms with the relevant guidelines and meets the required standards. From the earliest stages of drug development all the way through to dossier submission and post authorization life cycle management, all work carried out by every employee at Licensely is in the context of the regulatory requirements.
Our regulatory procedures team also acts as the hub from which the work of our technical teams, for pharmaceuticals and biologicals, is coordinated in preparation for regulatory submissions. Communicating progress and timelines internally, with our clients and their business partners facilitates efficient working practices and allows for crucial project deadlines to be met.
Our processes outlined here showcase typical development stages, highly customizable to corporate specifications.
Ensuring systematic layout mapping through local, regional, and international legal guidelines to secure clear authorization footprints.
High-tier compilation of quality, preclinical, non-clinical, and clinical summaries tailored for stringent board review panels.
Clean alignment with technical risk classifications and toxicological evaluation parameters requested by health authorities.
Formulation of proactive verification strategies, mitigation frameworks, and active safety profile monitoring channels.
Artwork auditing, structural packaging text screening, and product claim reviews to prevent promotional non-compliance.
Maintenance of Marketing Authorizations. Getting your product onto the market is a major regulatory hurdle, but the challenges don't stop there.
Comprehensive Indian structural directives and authorization frameworks outlined below.
Indian Regulations & Guidelines: Drugs
Pharma Regulatory Organizations & Acts - India
These are the bodies that perform various functions for Drugs & Cosmetic regulations in India. We offer consultation and execution of all formalities in order to clear compliance and regulations. This is to create market authorization for manufacturers, importers & distributors in India.
NPPA: For drug pricing & other orders. National Pharmaceutical Pricing Authority (NPPA) is under the Government of India. The Drugs & Cosmetics Act, 1940. The Pharmacy Act, 1948: In order to regulate the profession of Pharmacy in India. Objectionable Advertisement Act, 1954: This act discourages advertisement that state miraculous or magical effects of drugs and cosmetics.
For prevention of distributions, manufacture and sale of narcotic drugs in India.
Dossier is a document file which has administrative quality, clinical & non clinical. which is need to submit in Food & Drug Administration of the concerned Ministry of Health, of Regulatory Authority.
Licensely Provides Dossier service in Preparation, Review and rectify the quires as per the respective Regulatory Authority Guidelines. We are following as per ICH M4 (Common Technical Document). We are offering Asian, Africans & CIS Market.
Comprehensive regulatory management across six foundational enterprise sectors.
One-Stop Solution to all your Development, Formulations, Artwork, and Licensing needs under one roof.
Licensely provides the ultimate identification map for your product, meeting your budget and strategic resource plans perfectly.
Connect directly with our corporate registration coordinators to fast-track your approval pipeline.
+91 94984 50013
tpracindia@gmail.com
Perungudi & Alathur — Chennai, India