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- Medical Device Classification Support in India (As Per CDSCO)
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- Successful Authoring of 45 Protocols and Protocol Amendments
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- Successful CCDS Management and HA Audit Support
- Successful Change of RP and the Product Re-notification in the EU
- Successful Classification & Registration of Medical Device in Vietnam
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- Successful Classification of Medical Device as per the Regulations of CDSCO
- Successful Classification of a Cosmetic Product in Multiple Markets
- Successful Compilation And Submission Of The Annual Report 2018
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- Successful Conversion of 17 Existing DMFs into eCTD
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- Successful DMF Filings in the USA and Canada
- Successful DMF Submission to the Health Canada
- Successful DMF Submission to the USFDA with Zero Deficiency
- Successful DMF submissions within one week that yielded 70% cost benefits
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- Successful Establishment of Audit-ready Processes And Management Systems
- Successful Execution of More Than 250 Clinical Trials across Locations
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- Successful GMP Audit Services Avoiding Potential Non-conformances
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- Successful IND Submission in 4 Weeks saving 70% on Cost of Compliance
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- Successful Ingredient Assessment as per the USFDA’s Guidelines
- Successful LCM Submissions and Validation with Freyr SUBMIT PRO
- Successful MAA Filings with Zero Deficiency
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- Transfer of Ownership of ANDA for 31 Products in a single day
- Transfer of Ownership of ANDA for 6 Products
- Two Step Review Process for Accelerating DMF Submissions
- UDI Submission to the GUDID Database for Moderate Risk Devices
- Update the CTD Dossier and Successful Submission of ‘Type C’ Amendment
- Updating Clinical Evaluation Report (CER) for EU MDR Compliance
- What Is A Scientific Validity Report (SVR)?
- ZACTD Preparation with ‘Type A’ Amendments
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