Freyrsolutions

Contact Freyr for End-to-End regulatory services in Sri Lanka to comply with NMRA regulatory Requirements.

Freyr provides cosmetic regulatory services in Sri Lanka as per NMRA and CESC during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation.

Freyr provides food regulatory services in Sri Lanka as per NMRA and FCA during food product registration, classification, formulation, ingredient assessment and technical dossier compilation.

Freyr provides medical device regulatory services in Sri Lanka during medical device registration, classification and licensing as per NMRA regulatory requirements.

Freyr provides pharma/Medicinal product regulatory services in Sri Lanka as per NMRA during Medicinal Product Registration, Market authorization and Dossier Gap analysis.

Freyr provides regulatory services and solutions in Sri Lanka to comply with NMRA to pharma, medical device, cosmetics and food supplement manufacturer companies.

Freyr helps medical device manufacturers with language translation, editing of medical device technical information in IFU, DSURs, SUSARs, Package inserts & labels for submission & approval process as per targeted regional languages with compliance to ISO 17100:2015 & ISO 9001:2008 standards.

Freyr provides Staff Augmentation Consulting services for medical device manufacturers that span across several Regulatory functionalities from associate to expert level resources and 24X7 time zone coverage model to support multiple time zone and office coverage.

Freyr provides regulatory supports for medical devices and In-vitro diagnostics (IVD) manufacturers in registration, regulatory submissions, dossier compilation, GAP analysis, premarket notification, local agent services and classification as per country-specific regulatory requirements for compliant market entry.

Freyr provides regulatory strategy consulting services for medical device manufacturers looking for global expansion in complex markets like APAC, MENA & LATAM and supports in device registration, classification, assistance with notified body selection and regulatory submissions.

Freyr provides regulatory support to the medical device manufacturers in De-Novo registration of medical devices in the USA that span across classification, Pre-Submission/Q-Submission meeting request, risk benefit determination, De-Novo submission package compilation, publishing and creation for Pre-Submissions.

Freyr provides regulatory intelligence services for medical device manufacturers to meet region-specific health authority requirements for compliant market entry of their products and provides comprehensive regulatory Intelligence reports corresponding to organizational needs basing on the region and device type.

Freyr provides medical device regulatory compliance, gap analysis and remediation services for medical device manufacturers that span across UDI, GDPR, EUDAMED compliance support, post approval compliance support, Consultation and representation services for ISO 13485:2016, MDSAP, BGMP and establishment of QMS document

Freyr provides labeling and promotional material regulations support for medical devices manufacturers, which include creation & review of IFU (Instructions for Use), UDI compliance, GAP analysis, comprehensive artwork check, tracking and maintaining label changes.

Freyr provides labeling services for medical device manufacturers that span across label creation, review of IFU (Instructions for Use), Gap analysis, UDI, EUDAMED & EU MDR label compliance, tracking and maintaining label changes as per regulatory requirements.

Freyr provides regulatory support for medical device manufacturers in device technical file publishing, which include creation, review, validation, compilation and device technical file submission in electronic format to meet country specific health authority requirements for compliance.

Freyr provides regulatory support for medical device manufacturers in preparation of Design History File (DHF) document, which include Design Plan, Design verification & validation, Risk Analysis, hazard identification and Human Factor Analysis to meet US FDA compliance requirements.

Freyr provides ISO 14971 Risk Management consulting services for medical device manufacturers that span across preparation of comprehensive remediation plan, gap analysis, development of ISO 14971 document and post-Market Surveillance support to ensure the safety and efficacy of medical devices.

Freyr helps In-Vitro Diagnostic Device (IVD) manufacturers in Performance Evaluation Report (PER) preparation, development of Performance Evaluation Plan, collecting & assessing the clinical evidence data, review and submission as per EU IVDR regulations for compliant market entry in Europe.

Freyr provides Post Marketing Surveillance (PMS) support for medical device manufacturers, which includes development of PMS strategy, identifying the requirements to meet EU MDR standards, PMS data review, compilation and evaluating the data as per country specific compliance requirements.