Freyr Secures USFDA 510(k) ClearanceFor Cocoon Medical’s Elys

www.freyrsolutions.com/freyr-secures-usfda-510k... - Details

FreyrSolutions: New Jersey – June 08, 2020: Freyr, a leading global Regulatory solutions and services company, announced that the organization has obtained the US Food and Drug Administration’s(US FDA) 510(k) clearance for Cocoon Medical – a Spain-based...

to tags: 510  k  clearance  premarket  approval  usa  device  compliance  us  ...

Food Label Review, Food label claims, Nutrition facts label, Fo

foodsupplements.freyrsolutions.com/labeling-rev... - Details

FreyrSolutions: Freyr provides food label review services for Nutraceuticals/dietary/food supplements companies to meet country-specific labeling compliance requirements.

to tags: nutrition facts label  food label compliance  food label claims  food label review 

US FDA's guidance for drug sponsors on pediatric study plans

www.freyrsolutions.com/blog/fda-guidance-the-ne... - Details

FreyrSolutions: This article talks about the FDA issued final guidance for drug sponsors on planning and submission of Initial Pediatric Study Plan(iPSP).

to tags: fda  pediatric  study  plan  us  guidance  template  final  plans  ...

Regulatory updates on European Pharmaceutical Industry

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FreyrSolutions: This article talks about the Regulatory updates on pharmaceutical industry for medicinal products manufacturers who are willing to market their products across Europe.

to tags: european  agency  updates  medicines  regulatory  clinical  practice  (gcp)  ema  ...

South Korea’s MFDS released safety rules for Custom Cosmetic

www.freyrsolutions.com/blog/mfds-outlines-safet... - Details

FreyrSolutions: This article talks about the South Korea’s MFDS released draft guidelines detailing safety rules for personalized/custom cosmetics manufacturers.

to tags: cosmetics  mfds  standards  south  personalized  korea  safety  product  rules  ...

EMA’s guidance on GMP and GDP flexibilities during Covid-19

www.freyrsolutions.com/blog/covid-19-emas-gmp-a... - Details

FreyrSolutions: This article talks about the EMA’s temporary updated guidance on GMP(Good Manufacturing Practices) and GDP(Good Distribution Practices) regulatory flexibilities for quick market entry of medicinal products during Covid-19 pandemic.

Pharmaceutical Regulatory Affairs, Pharma CMC, Regulatory CMC S

www.freyrsolutions.com/pharmaceutical-regulator... - Details

FreyrSolutions: Freyr provides Regulatory Affairs services to Pharmaceutical Companies for drug classifications, drug registrations, licensing and obtaining market approvals with focus on the entire Pharmaceutical Regulatory Affairs value-chain.

to tags: drug  classification  registrations  support  cmc  regulatory  affairs  pharma  pharmaceutical  ...

Generics Regulatory Services, Generic Drug Registration

www.freyrsolutions.com/generics-regulatory-serv... - Details

FreyrSolutions: Freyr Provides Regulatory Affairs Services to Generic drug companies that span across lifecycle management, generic Regulatory CMC, post-approval submissions, annual reports, renewals, compilation and submission for already approved NDAs/MAAs/ANDSs/Dossiers/DMFs/CEPs.

to tags: generics  cmc  registration  anda  drug  generic  regulatory  services 

Biologics Regulatory Affairs, Biologics CMC, Biologics Regulato

www.freyrsolutions.com/biologics-regulatory-aff... - Details

FreyrSolutions: Freyr provides Regulatory Affairs services to the biologics medicinal products during market authorization, lifecycle management (LCM) support, HA regulatory requirements and Global registration support.

to tags: biological  medicinal  products  services  cmc  regulatory  affairs  biologics 

Regulatory Affairs Services, Regulatory affairs consulting

www.freyrsolutions.com/regulatory-affairs-servi... - Details

FreyrSolutions: Freyr Provides global Regulatory Affairs Services to Pharma, Biotech and Bio-Med companies to comply with Health Authority regulatory requirements.

to tags: regulatory  affairs  consulting  services 

Food Health Claims, Claim Substantiation, Food supplements

foodsupplements.freyrsolutions.com/claims-consu... - Details

FreyrSolutions: Freyr offers Nutraceuticals/Food/dietary supplements health claims services, which includes claims substantiation, formulation review, food label claims review, literature review and preparation & submission of claims application for food manufacturing...

to tags: food supplements  claims consultation  food label claims  food health claims  claims substantiation 

Functional Food Claims Review, Nutrient Function Claims

foodsupplements.freyrsolutions.com/claims-revie... - Details

FreyrSolutions: Freyr supports Nutraceuticals/ Food/dietary supplements manufacturing companies in Food Claims Review services across the globe.

to tags: literature review  food supplements  nutrient food claims  food claims review 

UK's MHRA issued a new guidance on Post Brexit Medical Device r

www.freyrsolutions.com/blog/role-of-mhra-and-po... - Details

FreyrSolutions: This article talks about the UK's MHRA issued a new guidance on post Brexit medical devices regulations that will commence from January 1, 2021.

Food product dossier compilation, Food supplements

foodsupplements.freyrsolutions.com/technical-do... - Details

FreyrSolutions: Freyr assists food supplement manufacturers in technical dossier/document compilation, safety report preparation, review and gap analysis required during product registration/notification.

to tags: nutraceutical product dossier compilation  food supplement  gap analysis  nutraceuticals dossier compilation  food supplements 

Legal representative, Food product registration, Food supplement

foodsupplements.freyrsolutions.com/legal-repres... - Details

FreyrSolutions: Freyr offers legal representative services to food supplement manufacturers in product registration, post-marketing and serve as a liaison between manufacturer and HA in taking up all applicable regional responsibilities.

to tags: nutraceuticals  food supplements  food product registration  legal representative 

Classification of Food products, Nutraceuticals Classification,

foodsupplements.freyrsolutions.com/food-and-foo... - Details

FreyrSolutions: Freyr helps food supplement manufacturers in product classification, formulation review, pre formulation assessment, reformulation and identifies prohibited ingredients to meet region specific compliance requirements.

Regulatory intelligence, Food Products Marketing Strategy, Food

foodsupplements.freyrsolutions.com/food-and-foo... - Details

FreyrSolutions: Freyr provides regulatory intelligence services for the food supplements companies in product registration, classification, notification, licensing, Market Authorization Holder (MAH), legal representation requirements for compliant market entry...

to tags: food products marketing strategy  regulatory intelligence  regulatory intelligence services 

Food Product Registration, Food Supplement Registration, Classi

foodsupplements.freyrsolutions.com/food-and-foo... - Details

FreyrSolutions: Freyr assists food supplement manufacturers in product registration, notification, classification, GAP analysis, safety reporting, technical dossier compilation and submission for compliant market approvals.

to tags: nutraceutical regulatory requirements  food product  food product registration  food supplement registration 

Formulation Review, Food Ingredient Assessment, Food supplement

foodsupplements.freyrsolutions.com/formula-revi... - Details

FreyrSolutions: Freyr provides end to end regulatory support for food supplement manufacturers in formulation review, ingredient assessment and region-specific food product classification.

to tags: food safety risk assessment  food ingredients analysis  food ingredients  ingredient assessment  formulation review 

Immune Boosting Supplements, Food Registration, Immunity Boosti

foodsupplements.freyrsolutions.com/immunity-boo... - Details

FreyrSolutions: Freyr supports immune boosting supplement manufacturers in product registration, notification, classification, dossier preparation, compilation & submission, label compliance, claims review, formulation review, safety assessment, artwork design...

to tags: dietary supplements  food supplements  immunity boosting  nutraceuticals  immune boosting supplements