Medical Regulatory Writing Services
• New Product Authorization- IND, NDA, ANDA
• Post Approval Changes and Product Lifecycle Management
• Clinical and Non-Clinical Overviews
• Clinical Expert Statements
• Bio waiver Expertise
• eCTD/CTD dossier compilation for regulated & semi-regulated market
•FDA/SFDA/CDSCO/DCG related regulatory filing/ Submissions/Approvals
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Indivirtus Group of Companies
Indivirtus offers cost effective solutions to healthcare, Insurance, Data management and Book Keeping industry in a time bound manner.
Indivirtus help the industry to maximize their efficiencies in its core competencies while taking care of some of the specific areas of our expertise thus help them grow their business.
We, at Indivirtus, have the state of art facilities and fully secured migration framework for Pharmacovigilance, Health economics and outcome research, Clinical trials, Bioavailability studies, Bioequivalence studies, Medical billing, Insurance claim processing, maintaining the accounts receivables, generating and sending reports to the client, etc., thereby ensures total client satisfaction.
We have a highly experienced and dedicated team for complete documentation using high-end hardware and software to provide speedy solutions.
We, at Indivirtus, have the state of art facilities and fully secured migration framework for Pharmacovigilance, Health economics and outcome research, Clinical trials, Bioavailability studies, Bioequivalence studies, Medical billing, Insurance claim processing, maintaining the accounts receivables, generating and sending reports to the client, etc., thereby ensures total client satisfaction. We have a highly experienced and dedicated team for complete documentation using high-end hardware and software to provide speedy solutions.
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Category: Medical Writing
Tags: cdsco, clinical expert statements, clinical writing, dcg, FDA, medical regulations, medical writing, non-clinical overview, regulatory filing, regulatory writing, sfda
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