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      • 100% Accurate MAA and Baseline Submission in Middle East and Switzerland
      • 100% Accurate Submissions to USFDA
      • 100% Accurate and High Quality DMF Submissions in eCTD Format
      • 150+ MA’s successfully Submitted within 1 Month Increasing the Cost Benefits By 50%
      • 24x7 Artwork Creation and Proofing Services in India
      • 24x7 Artwork Creation, Proofreading, And QC Services
      • 24x7 Regulatory Support for LCM Submission
      • 24x7 Regulatory Support for Original NDA Application
      • 24x7 Support with Global Delivery Model to Meet Stringent Deadlines
      • 345, 177 and 198 Submissions for ROW, EU and US Respectively Within 3 Months With 100 % Acceptance
      • 70 Submissions in Three Months with Zero Defect Quality
      • 8000+ Successful Submissions in eCTD Format to Multiple Regions
      • ANDA and PADER Submissions with Zero Deficiency
      • Accelerated ASMF submissions in the EU within two weeks
      • Accelerated AnnexH Report Generation with RIMS Software
      • Accelerating Ahead Of Competition Delivering Faster Time to Approval
      • Accelerating the Approval Process for Baseline Submissions
      • Accurate and Compliant Original IND Filings and Amendments
      • Artwork Centralization & migration of 11,000 legacy artworks
      • Artwork Co-ordination and Proofing Services with Quick TAT
      • Artwork Creation and Technical Review For Successful Indian Market Entry
      • CAPA, RCA, and Audit Finding Closures within Two Days
      • CCDS Process Establishment to Audit Preparedness and Support
      • Closure of External Audit Findings
      • Collation and Gap Analysis of Regulatory Documentation for Cosmetic
      • Compilation and Easy Filing of the Variations
      • Compilation and Preparation of CDS for 80 Products
      • Compilation and Submission of ANDA as per RTR requirements
      • Compilation of Clinical Evaluation Report (CER) as per the EU Guidelines
      • Compilation, review, and submission of amendments Update for 4 products
      • Complete Review and Compilation of Module 1
      • Completion of GMP Audits for Two Sites
      • Compliance Check for Hand Sanitizer in Multiple Markets
      • Compliant Cosmetic Ingredients Assessment in Japan
      • Compliant Formulation, Claim and Label Assessment for the US Market
      • Compliant GMP Audit Services for API Suppliers in Switzerland
      • Compliant IND Submissions to the USFDA with Quick TAT
      • Compliant and Accurate Conversion of NeeS Documents into eCTD Format
      • Comprehensive Gap Analysis and Successful Submission to the USFDA
      • Comprehensive Gap Analysis of the Labeling Based on 21CFR801
      • Comprehensive Regulatory Artwork Support with 99.99% Quality Deliverables
      • Cosmetic Ingredients Assessment as per the CFDA Guidelines
      • Cosmetics Product Compliance check in Indonesia
      • Critical Submissions in a Record Time of 1 Day
      • DMF CTD Conversion and eCTD Publishing for Type II and IV DMFs
      • Delivered Multi-Country Filings, Staying Ahead Of Guidelines
      • Development of IND Templates
      • Device Classification, Regulatory Approach Identification and Registration Services in Mexico
      • Device Regulatory Strategy and Submission Services in India
      • EMA Compliant Health Based Risk Assessment (PDE)
      • EU Claims Support and Notification of Cosmetic Products on CPNP
      • Effective Health Authority Interactions for 156 Successful Variation Submissions
      • Enabling Critical Regulatory Market Positioning and Product Launch Strategies
      • End-To-End Paper to DIN eCTD Submissions In a Single Day, Reducing The Time For Approval
      • End-To-End Regulatory Services For Registration of Multi-Component and Multi-Variant Devices in India
      • End-to-End Artwork Process Transition with Zero Recalls
      • End-to-End Cosmetic Product Compliance Check in Japan
      • End-to-End Cosmetic Products Notification Services in the EU
      • End-to-End Device Registration and Market Authorization Holder (MAH) Services in Thailand
      • End-to-End Gap Analysis of the Raw Data, Compilation and Submission to the USFDA
      • End-to-End Gap Analysis with Submission of ANDA to the USFDA
      • End-to-End Implementation of A Validated Document Management System (DMS) for Labeling on OpenText™
      • End-to-End Product Compliance Check for Multiple Markets
      • End-to-End Regulatory Services for ARTG Listing and Australian Sponsor
      • End-to-End Regulatory Services for Device Registration in Sri Lanka
      • End-to-End Regulatory Services for Device Registration in the USA
      • End-to-End Regulatory Services for SaMD Registration with the ANVISA and BRH Support
      • End-to-end Gap Analysis and consultation for Marketing Authorization Submissions @ SFDA
      • End-to-end Gap Analysis for IDMP Readiness across Europe
      • End-to-end Gap Analysis, Compilation of ANDA for Submission to the USFDA
      • End-to-end Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions
      • End-to-end Regulatory Support for Legacy Device’s EU MDR Transition
      • End-to-end Regulatory Support for ODD in the USA
      • End-to-end Toxicology Risk Assessment services for Perfumes in European Economic Area
      • Error-Free IND Submissions with Quick TAT
      • Error-free Artwork Centralization with 50% Cost Savings
      • Error-free Major Variation Submissions in eCTD format to Australia
      • Establishing CCDS Process and Preparing for Audit-readiness
      • Establishing SOPs for QMS/ISMS Remediation
      • Establishment of Regulatory Affairs Team and Finalization of 40 SOPs
      • Evaluation and Submission of Response to Information Request
      • Evaluation and Submission of Response to Screening Deficiency
      • Expedited Product Classification and NIOSH Certification for N95 Respirator
      • Expert Opinion on EU GMP Guidelines
      • Filing Compliant Original Submissions with 100% Accuracy
      • First successful NDA-Medical Device Submission Made with Reduced Delivery Time from 50 days to 16 Days
      • First-Time-Right Solution For 99.7% Tasks for UDI Submission
      • First-time-right Safety Assessment Services Across the Europe
      • Freyr Deck Regulatory Support for Hand Sanitizer Product Classification in Japan
      • GCP Audit Services for EU submission in quick TAT
      • GMP Audit Services for Establishing Management Systems Post-Acquisition
      • GMP Audit Services with Quick TAT
      • GMP Audit and Compliance Services
      • GMP Audit as per the MHRA Guidelines
      • GMP Audit with End-to-End Gap Analysis
      • Gap Analysis and Compilation of Design Control Documents
      • Gap Analysis and Successful submission of ANDA to USFDA
      • Gap Analysis and review of ANDA as per FDA requirements and RTR
      • Gap Analysis and technical review of ANDA
      • Health Supplement Registration/Approval in Malaysia, Indonesia, Vietnam and Philippines
      • High Quality GMP Audit in Quick TAT
      • High-Risk Device Registration in Pakistan as per the MDR 2017
      • Initial Registration of Medical Device and Submission of MDMA
      • Initial Registration of the Product and Submission to the SFDA
      • Label Assessment and Claims Review for Oral Care Products in the USA
      • Label Assessment for Skin and Eye Products in the USA and Canada
      • Medical Device Classification Support in India (As Per CDSCO)
      • Mock Audit and Training for Stage II MDSAP Assessment
      • On Time, Compliant and Accurate Annual Reports Submission
      • On-Time Submission of DMF Applications in eCTD Format
      • On-time Delivery of 125 PDE Reports to the MHRA
      • On-time Delivery of 25 CSR Shells and CSRs
      • On-time Submission of 10 IBs for Multiple Regions
      • On-time Submission of Original Applications to the USFDA
      • One-Time Marketing Status Update to USFDA
      • Performed Gap Analysis and Successful Submission of ANDA to the USFDA
      • Performed Gap Analysis with Full Support in Strategy and Preparation of Response to the USFDA
      • Preparation And Submission of DMF Amendments in eCTD Format to FDA, TPD
      • Product Correspondence for USA Agent Change
      • Product Registration and Variation Submissions to 12 African Countries
      • Publishing and Validation of eCTD Dossier with Successful Submission to the SFDA
      • QA Consultation Services with Internal QMS for Implementation and Closure of CAPAs​
      • QMS / ISMS Remediation Along with Software Validation
      • QMS Remediation And Audit Services
      • QMS Remediation Services Along with End-to-End Gap Analysis
      • QMS Remediation and Audit Finding Closures in Saudi Arabia
      • QMS Remediation and Gap-Analysis Services
      • QMS Remediation and SOP Rationalization for Audit-readiness
      • QMS Remediation and SOP Rationalization for On-Time Audit Readiness
      • Quick SOP standardization and Rationalization to Streamline the Processes
      • Quick TAT for GCP Audit Services
      • Quick TAT with 100% Accurate ANDA Filings
      • RI Report on Digital Clinical Trial Data Capture System in the US and EU
      • Registration of In-Vitro Diagnostic (IVD) Device in Brazil
      • Regulatory Assessment Report for Cosmetic Ingredients in South Korea
      • Regulatory Assessment Report on Acceptability of Ingredients in Taiwan
      • Regulatory Assessment of Ingredients as per the MFDS Guidelines
      • Regulatory Assistance for Compliant DMF Submissions
      • Regulatory Compliance for Infant Formula in Malaysia and KSA Markets
      • Regulatory Framework Report on Approval of Anti-viral Antisera Products in the USA and EU
      • Regulatory Intelligence (RI) Services for Food Supplements in Europe and Canada
      • Regulatory Intelligence (RI) Support for Food Labeling Information in the EU
      • Regulatory Intelligence on PPO Policies in India
      • Regulatory Intelligence on Stability Studies in Malaysia
      • Regulatory Services For Listing Newly Regulated Medical Devices in India
      • Regulatory Strategy and Submission Services
      • Regulatory Support For Successful PLLR Conversion
      • Regulatory Support for 24x7 Artwork Services
      • Regulatory Support for Accelerating Annual Report Submission
      • Regulatory Support for Audit Services and Inspection Readiness
      • Regulatory Support for Filing ANDA Applications while Reducing Overall TAT
      • Regulatory Support for Food Supplements Classification in Canada
      • Regulatory Support for Ingredient and Label Assessment in the UK
      • Regulatory Support for Product Compliance, FSSAI License and Import Services in India
      • Regulatory Support for Submission of Complex CSRs
      • Regulatory Support for Technology Based Product Classification in the US
      • Regulatory Support with QA Services
      • Remote Internal Audit of QMS Systems for 21 CFR 820 and ISO 13485:2016 Compliance
      • Review and Gap Analysis of Raw Materials Across the EU, JAPAC, Middle East, ROI and ASEAN
      • Review of Administrative Documents with Successful eCTD Dossier Submission to the SFDA
      • SOP standardization and Submission of 10 Nonclinical Overviews
      • Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
      • Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
      • Streamlining the Assessment Process for PLLR Category Removal
      • Submission of CBE 30 within 3 days
      • Submission of DMF for Genomic Assay Method to USFDA
      • Successful 50+ SPL Submissions In 20 Days
      • Successful ANDA Filing with zero deficiency
      • Successful ANDA Submission to the USFDA with End-to-End Gap Analysis
      • Successful ANDA and DMF Submissions to the USFDA and Health Canada
      • Successful ANDA and DMF Submissions with Increased Cost-Benefits
      • Successful Artwork Updation with 99.99% Quality of Delivery
      • Successful Authoring of 45 Protocols and Protocol Amendments
      • Successful Authoring of 60+ Submission Ready ICFs
      • Successful BLA Submissions with Zero Deficiencies for US Region
      • Successful Baseline Paper to eCTD submissions to GCC Oman
      • Successful Change of RP and the Product Re-notification in the EU
      • Successful Classification & Registration of Medical Device in Vietnam
      • Successful Classification & Registration of Medical Device in the US and EU
      • Successful Classification & Registration of Medical Device with the TFDA
      • 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
      • Successful Compilation and Submission of CSR in 7 Days
      • Successful Completion of 4 High Quality CSR Publishing in Short TAT
      • Successful Completion of GMP Audits within 2 Weeks
      • Successful Completion of NMC Meeting with COFEPRIS
      • Successful Conversion of 17 Existing DMFs into eCTD
      • Successful Conversion of 37 DMFs into eCTD Format
      • Successful Conversion of Type II DMFs into eCTD Format
      • Successful DIN Submissions in eCTD format to Health Canada
      • Successful DMF Conversion to eCTD and Submission to the USFDA
      • Successful DMF Filings in the USA and Canada
      • Successful DMF Submission to the USFDA with Zero Deficiency
      • Successful DMF submission to the Health Canada
      • Successful DMF submissions within one week that yielded 70% cost benefits
      • Successful Delivery of 30+ Protocols in less than 10 Business Days
      • Successful Delivery of Error-Free IND Submissions
      • Successful Delivery of High Quality NDA Applications
      • Successful Delivery of Scientific Validity Reports (SVRs) for 11 IVDs
      • Successful Execution of More Than 250 Clinical Trials across Locations
      • Successful Execution of Validation Procedure
      • Successful Filing of DMF and Amendments in the USA
      • Successful GMP Audit Services Avoiding Potential Non-conformances
      • Successful GMP Audit Services at Manufacturing Facilities
      • Successful GMP Audit with necessary suggestions and recommendations
      • Successful Global Regulatory Assessment and Roadmap Preparation
      • Successful GxP Audit for 15+ CROs under Short Timelines
      • Successful IND Filings in the US Region
      • Successful IND Submission in 4 Weeks saving 70% on Cost of Compliance
      • Successful IND and NDA Submission to the USFDA
      • Successful Identification of Medical Device Category in the EU Region
      • Successful Ingredient Assessment as per the USFDA’s Guidelines
      • Successful LCM Submissions and Validation with Freyr SUBMIT PRO
      • Successful MAA Filings with Zero Deficiency
      • Successful Management of Product Registrations with Freyr PRISM
      • Successful Medicinal Product Registration in Indonesia
      • Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)
      • Successful Preparation and Submission of 15+ IBs
      • Successful Product Classification & Compliance Check of an FSDU in India
      • Successful Registration of Mobile Medical App in the US and EU region
      • Successful Regulatory Artwork Support During M&A Within 3 Months
      • Successful Regulatory Support For DMF, ANDA Pre- and Post- Approval Activities
      • Successful Regulatory Support for A Technical Change with COFEPRIS
      • Successful Regulatory Support for Regional Labeling Operations and Process Improvement
      • Successful Regulatory Support for SPL submissions within two weeks
      • Successful Review of the Packaging Labels, Impact Analysis, and Submission to the USFDA
      • Successful Review of the Raw Data, Compilation and Submission to the USFDA
      • Successful SPL Submission in 2 Weeks, Increasing 50% in Cost of Compliance Benefits
      • Successful Submission of 80 CDS and Clinical Overviews
      • Successful Submission of 8000+ High Quality Applications
      • Successful Submission of Annual Reports in eCTD Format
      • Successful Submission of DMF and Annual Report in the US Region