India

Regulatory Affairs Services:

• Regulatory Strategy and planning for initial as well as post approval submissions for Europe, US, Canada and Australia.
• Management and support with scientific advice meetings with EU agencies regarding product development and/or MAA submission.
• Controlled correspondence and Pre-submission meetings for US.
• Management and Preparation of all types of Regulatory Submissions throughout the product life cycle for Europe, US, Canada and Australia.
• IMPD-Quality dossier preparation for Clinical trial application to EU
• CPP application to EU agencies in support of product export to other countries
• Preparation and review of mock-ups

Initial submissions:

• Due diligence or technical gap analysis of old dossiers/dossiers of other market to extend the submission in Europe, US, Canada and Australia.
• Dossier CMC module writing and compilation for Europe, US, Canada and Australia.
• Module 1 preparation for all type of submissions for Europe, US, Canada and Australia.
• Product information preparation – i.e Europe-SmPC, Labelling, PIL, US-Pack insert, Medication guide, Labelling, SPL, Canada- Product Monograph, Labelling, Australia-Product information, Package insert, CMI.
• Preparation of Module 1.7.1 Orphan similarity report for Europe submissions
• National phase package preparation for Europe submissions
• Review of Elemental & Nitrosamine impurity risk assessment reports
• NDC labeler code request for US
• Drug Establishment License application for Canada

Drug substance submissions

• ASMF/CEP/US DMF/Canada MF dossier writing and compilation

Life Cycle Management

Europe

• Variations (major, minor, separate, groupings)
• Renewal
• Market authorization transfer
• Cancellation of marketing authorization
• Submission of labelling changes applications
• Sunset clause exemption applications
• Hands-on support and troubleshooting of any issues throughout the approval process

US

• Post approval changes (PAS, CBE, Annual reports, amendments)
• Market authorization transfer
• Field Alert Reports
• Establishment registration
• Facility self-identification

Canada

• Post approval changes (Supplements, Annual reports)
• Market authorization transfer

Australia

• Post approval changes (Correction to ARTG entry, Notifications, Self-assessable requests (SARs), Category-3 variations)
• Transfer of sponsorship

Document and Submission Publishing

• Legacy document conversions, submission readiness of pdf documents to eCTD standards, and compliance with regulatory and customer-specific standards
• Global eCTD dossier compilation, validation, and publishing

Medical team:

• Preparation of non-clinical and clinical modules and respond to regulatory queries
• Review of clinical study documents
• Preparation of IB
• Bioanalytical audits and audits of clinical trial sites
• Preparation of non-clinical and clinical strategy documents
• Preparation of briefing package for regulatory meeting
• Preparation of medical justification
• Provision of medical and safety expert in clinical trials.

Pharmacovigilance activities:

• Case Management [Downloading, Triaging, Data Entry, Medical Review, Quality Check, Archival / Submission (EMA/USFDA)]
• Signal Management
• Preparation and Review of Risk Management Plan (RMP)
• Preparation and Review of Periodic safety update reports (PSUR) / Periodic Benefit-risk Evaluation Reports (PBRER)
• Preparation and Review of Periodic Adverse Drug Experience Report (PADER)
• Preparation and Review of Addendum Clinical Overview (ACO)
• Literature Monitoring (through Pubmed)
• Local Literature Monitoring
• Regulatory Monitoring (EMA / MHRA)
• Management of Extended EudraVigilance Medicinal Product Dictionary is a database (xEVMPD database)
• Provide support in audit / inspection