We support our client's product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies. We cater from local to global submissions. Having a better understanding of the Indian regulatory scenario, we provide the best assistance to resolve any queries raised by the "Drug Controller General of India" (DCGI) and follow-up submissions for faster approvals.

What we do for you:

• Preparation of Regulatory Dossier.
• Regulatory strategy planning for faster approval.
• Filing of submissions, tracking submissions & query resolution.
• Post - approval regulatory submissions (amendments).
• Submission of final study reports.
• Preparation and submission of Product Registration applications, to import, manufacture and market in India.
• Complete Import & Export License Management for clinical supplies and biological product and samples.