Product Selection, Filing Strategy, Operation

Regulatory

Our team is experienced in preparing, compiling filing and obtaining approvals for various classes of products from Regulatory Agencies in the US, Various European Agencies under MRP and Non- MRP filings, Canada, India, several African, South American and Asian agencies.  We help customers strategize product selection, filing strategy and approach, and do all the necessary Regulatory work throughout the lifespan of a product.

Strategic Planning, Products & Filings

Prepare ANDA Filings

eCTD and CTD Filings in the US & across Europe

Annual Reporting

NDA Filing

Respond to Queries

Work as a team with R&D,  Manufacturing & Quality teams 

Liaison with Regulatory Agencies

Medical Information & Query Tracking

 

Our team of highly skilled safety professionals is ready to design and deploy a solution specifically customized to our customers needs. We build solutions keeping in mind the size of the organization, number of products/authorizations, case load and other relevant parameters to ensure the overall process is compliant and remains cost effective.

Call us or write to us for a quick overview of our services and to determine if we can indeed help you with your Regulatory needs.