Our services:

• Regulatory Strategy - Strategic design for the global regulatory submissions including the key markets of the UK, EU, USA, and Canada, but not limited to.
• Regulatory Submissions - Gap Analysis/ Due-diligence and dossier review.
• eCTD review, submission and publication.
• Customized support on specific modules as per need can also be provided.
• Query Management - Handling query responses from the regulatory authorities.
• Life Cycle Management Support - license renewals, annual reports, variation submissions, change of ownership applications, etc.
• Labelling Management – PIL, SmPC, US labels preparation, and management of updates.
• Bridging studies and user testing/Readability testing in the EU.
• General regulatory requirements for the above-mentioned market.
• Correct RLD identification/procurement.
• Establishing UK subsidiary and arrangement on batch release site/ QC testing lab/QP/MIA
• API supplier identification and its evaluation
• Regulatory services for the ROW/Emerging market including India Market.
• Bio-waiver strategy