Freyrsolutions

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.

Freyr provides regulatory support for medical device manufacturers in preparation of Clinical Evaluation Report (CER), which includes report writing, GAP analysis, PMS data support for existing devices and updating CER as per EU MDR guidelines/regulations.

Freyr provides medical device regulatory services in LATAM that span across medical device registration/notification, local representation support for compliant market entry

Freyr provides medical device regulatory services in RoW Market that span across medical device registration, notification and local representation services for successful and compliant market entry of products.

Freyr provides end-to-end regulatory services for medical devices manufacturers in Europe to comply with the new EU MDR regulations for successful market entry and also provides necessary Regulatory actions needed for the transition.

Freyr provides regulatory support for medical device manufacturers in classification of their products as per the new European Medical device regulation (EU MDR)/In-vitro diagnostic regulation (IVDR) for product compliance.

Freyr provides regulatory support for medical device manufacturers in 510k submission (510 k premarket notification) to USFDA, which include predicate device identification, 510k application compilation, gap analysis, publishing, creation & validation of e-copy, device listing for compliant market entry

Freyr provides regulatory support for medical device manufacturers in 513 g submission, which includes medical device classification, preparation & review of 513g application and interaction with agency to comply with CDRH, FDA.

Freyr acts as an authorized representative(AR) on behalf of the foreign medical device and In-Vitro Diagnostics (IVD) manufacturers in registration, pre-certification, post-approval, Marketing Authorization Holder (MAH) Services and also support for the Change of Legal Representative and Agency Interaction in Regional

Freyr acts as a local authorized representative (AR) on behalf of foreign medical device manufacturers in registration and market entry of their products in ROW countries and acts as a single point of contact in the Country for liaison with Regulatory Agency.

Freyr provides US agent representation services for medical device manufacturers and serves as a liaison between manufacturing company and FDA to be compliant.

Freyr acts as a European Authorised Representative (EAR/EC REP) for foreign medical device manufacturers in Europe to ensure their products are compliant with the European Directives and acts as a single Point of Contact in the Country for Liaison with Regulatory Agency.

Freyr provides post-Brexit regulatory scenarios for life Sciences manufacturers in UK & EU to be inline with new regulatory changes.

Freyr provides Brexit regulatory services for life science companies in most Affected areas like Artwork/Labelling/Packaging, Clinical Trials, GMP, MRP/DCP National/Central Procedure, Pharmacovigilance and Trade Barriers.

Freyr provides Global End-to-End post-Brexit regulatory services for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.

Freyr provides End-to-end post-Brexit regulatory services in European Union for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.

Freyr provides End-to-end post-Brexit regulatory services in United Kingdom for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.

Freyr SUBMIT Pro is an cloud hosted, on-premise cost effective eCTD submission software with features like eCTD Submission tracker, Viewer, Validation and rDMS Integration.