Freyrsolutions

Freyr provides regulatory services and solutions in India to comply with CDSCO regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies.

Freyr provides End-to-End Regulatory Solutions & Services in Australia to the Pharma Innovator, Generics, Biologics, Medical Device, Food Supplements, and Cosmetic Companies to comply with TGA Regulations.

Freyr provides Swiss Authorized Representative(CH-REP) services for medical device manufacturers outside the Switzerland as per Swissmedic regulations.

Freyr provides United Kingdom Responsible Person(UKRP) services for medical device manufacturers outside the UK as per MHRA regulations.

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 Swiss Authorized Representative(CH-REP) services for foreign medical device manufacturers and acts as Swiss distributor/importer of devices across Switzerland.

Freyr provides Swiss Authorized Representative(CH-REP) services for medical devices and IVD manufacturers in CE marking and labeling support as per Swissmedic regulations.

Freyr provides United Kingdom Responsible Person(UKRP) services for medical devices and IVD manufacturers that span across registration, UKCA marking, UK CE marking, UKNI marking and labeling support as per MHRA regulations.

Freyr provides United Kingdom Responsible Person(UKRP) services for foreign medical device manufacturers with end-to-end regulatory support for registration and market entry in UK.

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 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 services and solutions in Thailand to comply with Thailand FDA for pharma, medical device, cosmetics, and food supplement manufacturer companies

Freyr provides regulatory affairs consulting and partnering services to the life science companies during drug discovery, non-clinical & Clinical studies and Regulatory filings across globe

Freyr provides region specific Regulatory affairs and consulting services to the life science companies to launch their products in the new markets across the globe.

Freyr supports in delivering high-quality, comprehensive safety evaluation for ingredient and toxicological risk assessment (TRA) reports for pharmaceutical, cosmetics, medical devices, food and consumer products across the globe.

Freyr provides clinical trial auditing and monitoring services for both the clinical and bio-analytical phases of the Bioequivalence (BE) studies, Bioavailability (BA) studies, Clinical SOP preparation and review as per health authority regulations.

Freyr provides clinical labeling services to Innovative pharmaceutical companies during creation & review of Investigational brochure (IB), Target Labeling (TL), DCDS, FDA Target Product Profile (TPP), EU-draft SmPC during Drug Development Process.

Freyr provides Regulatory Affairs services to Innovator medicine product companies during NDS process with Health Canada, starting from pre-NDS meetings to submission of NDS/Market Notification and further Life Cycle Management (LCM) activities.

Freyr provides Regulatory Affairs services to the Innovator medicine companies during NDA filing process, starting from pre-NDA meetings to NDA submission and further life cycle management of the medicinal Product.

Freyr provides Regulatory Affairs service support to the Innovator medicine companies during IND filing process, starting from pre-IND meetings to IND submission and further to regulatory compliance & maintenance.