For development of Therapeutics, Devices & Diagnostics

Submissions Management

Implementation of an appropriate regulatory strategy is critical to efficient drug development and the successful approval of products. In addition to strategic capability our regulatory team has practical experience in implementing these strategies through submissions in a wide range of products and procedures.

Vyomus Consulting provides regulatory expertise and resources through all stages of product development to enhance submission preparation and achieve faster product approval. Vyomus Consulting has the expertise and experience in the preparation and management of all types of regulatory documentation associated with product development, approval and maintenance including application amendments and maintenance, Supplement preparation, maintenance and submission.

Regulatory input during the entire product life-cycle has a tremendous impact on marketing, new claim development, supply chain management and every aspect of the post-marketing phase. Vyomus Consulting has significant experience in helping customers maintain and enhance their valuable product licenses, and deliver strategic and practical support for all aspects including variations, supplements, labelling changes, renewals and extension applications.

Vyomus Consulting offers the following services in this area…..


The Regulatory Services team at Vyomus Consulting is flexible to fit your needs. We are aware that customers need a flexible approach to resourcing in times of increased work load, changes in headcount or skills shortage. These needs can be met by the skills, expertise and professionalism of Vyomus Consulting’s team, who have supported and guided customers through some of their most challenging projects. We can provide selected or comprehensive services either from our facility or onsite at your facility as required to meet your specific program needs.

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