Regulatory Operations – Chemistry, Manufacturing & Controls
Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.
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Regulatory Operations – Chemistry, Manufacturing and Controls (CMC):
Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than AARIYA. Among the most critical tasks on this path is the creation of dossiers in ICH agreed Common Technical Document (CTD) format. A well-prepared regulatory application can translate into a smoother approval process and faster entry to market, through:
Strategic Input for Product Development
Involving a regulatory expert early in the product development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs... READ MORE
New Product Authorizations
A well-prepared regulatory application can translate into a smoother approval process and faster entry to the market. AARIYA has a globally recognized Center of Excellence in this space with expertise in regulatory content authoring... READ MORE
New Market Authorizations – API
With a proven expertise in handling all types of API (chemical/ fermentation/ sterile/ biologicals), Excipient and Pre-mix master-file submissions to global health authorities, AARIYA is one of preferred Regulatory partner across the globe in regulatory writing...READ MORE
Health Authority (HA) Queries - Responses
AARIYA has a proven track record in handling HA queries for speedy approval and uninterrupted commercialization...READ MORE
Post-Approval Lifecycle Management
AARIYA understands the pivotal role post-approval activities play in the product life-cycle maintenance of a product, and has the Regulatory expertise to ensure your product licenses are maintained as correct, current, valid and ... READ MORE
Vision
To become a noble regulatory consultancy, delivering high quality regulatory support to clients for introduction of wide range of generic and branded products in the market.
Mission
We thrive to provide quality focused and flexible services to the utmost satisfaction of our clients building long-term relationship.
