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Pharma Regulatory Consulting and Intelligence Services

• Development of product and indication-specific global regulatory strategies

• Generic Product Development and Data Generation Support for Solid Orals and Injectables.

• Dossier Compilation and Submission Dossier Conversion (Non-CTD to CTD, ACTD, ECTD, NeeS, Country Specific or Regional Submission)

• Key Strengths in Europe : EU Product Registration, Renewal Management, Variations, Labeling Update Management, Life Cycle Maintenance, XEVMPD Submissions, Sunset Clause Exemption Application, National Phase Management, Agency Consultation

• CTD and eCTD submissions on all types of drug products, US and Canadian Drug Master file (DMF) for API, Excipients, Packaging Materials, Certificate of Suitability as per EP (CEP), Summary of Product Characteristics (SmPC), Periodic Safety Updates (PSUR)

• Expert for Key Emerging Markets : Australia, New Zealand, South Africa, Singapore, WHO Prequalification

• Pharmacovigilance Inspection Preparation and Support

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