Services

Regulatory Services

The heightened disease prevalence has globally stimulated life science companies to match it by augmenting the number of clinical trials.


In the background of stringent and evolving regulatory landscape, outsourcing the regulatory services to independent service provider has a dual benefit. It not only ensures life science companies to be compliant with rigid timelines but also turns out to be extremely cost efficient.


Our intellectually competent team can provide strategic and operational guidance on all regulatory operations during product development process including 

·  Forming satisfactory responses to queries from agencies
·  Scientific advice and interactions with regulatory authorities
·  Paediatric development and PIPs
·  Product dossier and document management
·  Labelling operational support
·  IDMP/ XEVMPD
·  Submission Publishing, including paper, NeeS and eCTD publishing
·  Document Publishing, including all submission types and formats

Responding to regulatory safety queries

Regulatory authorities may have questions about the safety or efficacy of your products for which prompt answers will be required.


Extensive experience and knowledge of our team will help you comprehend the queries and provide a holistic overview of the information demanded. Also, they will be able to tell you exactly which services need to be targeted for the query viz PV services or literature search or something else. In this scenario, it is of utmost importance to ensure that the problem is not compounded due to lack of precision so that you don’t end up in a vicious cycle of queries and answers.


A crystal clear vision topped by a precise well articulated response from our team can satisfy the queries instantly thus conserving your precious resources of manpower, time and money.


Copyright © 2018. Awinsa Life Sciences Pvt. Ltd. All rights reserved.