Our team of experts is well aware of your needs as well as the needs of regulatory authorities. To attain quick, hassle free registration of dossiers, a comprehensive registration knowledge and interpretation of guidelines is most warranted. At CliniExperts, we have thorough, comprehensive and up-to-date knowledge about the registration requirements of all MOH and FDA. Moreover, we have an incomparable expertise in filling and filing of dossiers and DMF. We strive to achieve complete client satisfaction by providing inclusive post query support.
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential and detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
CliniExperts provides Global Regulatory Service and DMFs solutions for Pharma Export Registration. We, with our dedicated and skilled technical team, write & review DMF/CTD- Section-3.2.S/QOS as per ICH CTD/ ASEAN CTD/ Country specific guidelines. We also assist in the publishing and submission of USDMF and EDMF to USFDA. We assist our clients during the Product Registration till approval. We provide the support to address the MOH queries received from time to time for other associated applicants, if needed.
This includes services as:
CliniExperts provides Regulatory Consultancy for International Dossier registration with Global geographical regions worldwide. We assist our customers to guide on know-hows about the kind of documents required for a specific country as well as to assist in drafting and finalizing the country specific administrative documents/CTD Module-1 and help them to minimize the short falls in the rejections/Refute -to-file during screening/validation phase of the Dossier submission & review at MOH/FDA.
The technical documentation involves primary documentation which supports an NDA or ANDA in the form of a DMF/ CTD. It compiles the Chemistry, Manufacturing and Controls (CMC) information for the drug substance, as per instructions mentioned in guidance documents from the US Food and Drug Administration (FDA) or the International Conference on Harmonization (ICH). The electronic version of full DMF is submitted to the international associated regulatory agency.
The information to be included is the summary of the manufacturing procedure (in the form of a flow diagram) which provides the identification of key raw materials, solvents, and intermediates used during the process. Secondly, analytical methodology used to assess the drug substance is of critical importance. Moreover, validation reports for the methods for assay, impurities and residual solvents are also included.
The comprehensive documentation of DMF involves the following:
CliniExperts is a one stop Global Regulatory Solution provider that assists their clients in seamless entry into Global regions by getting their products registered as per and well within the expected timelines with minimal anticipated queries with Right-at-first time approach. Support in full dossier writing as well review to Clients interested in Pharma Export Business. We prepare, write, review and finally submit the dossiers (as required) as per European/US CTD and ASEAN non-CTD/country-specific requirements to respective Health Authorities.
We have experience in guiding the Manufacturer/ Exporter/ Applicant in advance of pre-requisites and Requisites of Registration of product at target country (ies) and assisting them from end-to-end to registration of their product. This includes:
a) Administrative Documents:
CliniExperts provides cost effective Regulatory Consultancy services at your doorstep. Right from International Dossier registration, we assist our clients in achieving successful and timely submission around the globe. Our services include drafting of authorization letter, product labeling summary, preparation of label and carton contents, FDC justifications, etc. We also cater services to review legal & administrative documents.
b) Technical data/sections of Dossier:
CliniExperts assist its clients in writing and reviewing of all the sections included in a dossier preparation.
Our services include the following:
To achieve complete client satisfaction, we assist our customers in handling and solving the regulatory queries raised by healthcare authorities. We also provide query responding services. Our salient features include the following: