Post Approval Changes

Post Approval Changes

 

Though the registration of a DMF or a dossier requires extensive research, collation of data, regulatory knowledge, good compliance to guidelines, but, the post approval procedures such as post changes, re-registration etc. require brainstorming efforts. CliniExperts is a group of trained professionals with hands-on expertise in Global Regulatory Consultancy. We provide glitch free, regulatory compliant support for post registration services.  We ensure timely submission of all documents so as to get all registrations within the stipulated time period. Our team assists the customers to get their dossier approvals in the shortest possible time. We provide all the regulatory facilities under one roof to make it convenient for clients to reach us. Our team works rigorously to stay abreast with any updates which may influence the submission or approval procedure of the DMF.  We assure you best of our services in the following fields:

 

 

  • Regulatory Assistance in Post-Approval Changes/Variation (minor, major, critical):

The post approval changes which warrant re-submission of document involve modification in components and composition of the dossier, change in manufacturing sites, any minor to major variation in manufacturing process, any other specification, change in container closure system and extension in labeling and miscellaneous changes. Moreover, multiple changes related to the dossier can also be submitted. We assist the clients in upgrading the existing products pipeline by extensively searching and submitting additional data generated as per the regulatory requirements of the countries. Our support includes services right from planning, preparation to submission of the dossier.

 

 

  • Regulatory intelligence:

Any minor to major change in the regulatory standards or guidelines require a modification in the submission of dossier. We have instant and constant updates on changes in regulatory guidelines, which influence our dossier submission process. Pertaining to the regulatory changes, we also take care of the timelines to submit the application, the extended form of data required along with the DMF to accelerate the submission and approval process. By this, we provide 24*7 customer care to our clients and helping clear out the existing product stuck in approval pipelines.

 

 

  • Assistance in extension of labels, shelf life:

An extension in label can be minor, moderate or major. The extension in label is required if there is a modification in strength; variation in a contraindication, warning, precaution, or adverse reaction; any addition of drug abuse or dependence statement; any psychological effect; complication associated with over dosage; safety statement; deletion of any misleading statement. The extension in expiration date is also required to be submitted. It is accompanied with the supplement document in case the extension in shelf life is supported on some data obtained from study conducted on the modified dossier.

 

 

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