We provide comprehensive services related to the registration of drugs and preparation of Common Technical Document (Product Dossier). Common Technical Document (CTD) is an important part of any drug registration. A CTD has to be compiled and submitted in a requisite format to the drug authority and health ministry. We have a qualified and experience team of consultant who work closely with you to author, review and update your CTD at every stage. In addition, we can also assist you with other legal documents needed for market authorization as we fully understand this complex task that has the most demanding standards.

We Provide At Shree Krishna Pharmaceutical

01

We have a decade’s experience in preparing various documents and CTDs necessary for drug registration in countries in EU, Africa, the Middle East Countries and other regulated and semi-regulated markets.

02

We have a network of experts, including technical and regulatory experts, experts with experience in pharmaceutical, pharmacological, toxicological and clinical (CRO) areas, stability data, production and sales.

03

We provide drug registration and CTD services that are timely and cost-efficient and in accordance with all applicable regulatory authorities of the country of interest as required by the client.

We offer the following services:

• Writing and compilation of CTD for regulated and semi-regulated markets
• Assistance at every stage (pharmaceutical, non-clinical & clinical)
• Creating administrative, quality, non-clinical and clinical documents

Get in touch  today to earn more about our expertise and services registration activities.