Drug Registration & CTD
Why Choose Biomed Speciality Pharma?
We provide comprehensive services related to the registration of drugs and preparation of Common Technical Document (CTD).
Common Technical Document (CT) is an important part of any drug registration. A CT 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 CD 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.
Distribution
We have a decade’s experience in preparing various documents and CDs necessary for drug registration in countries in EU, Africa, the Middle East Countries and other regulated and semi-regulated markets.
Varied Network
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.
Cost-Efficient
We provide drug registration and CT 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.