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REGULATORY STRATEGY

consulting, planning and support

  • Regulatory submission strategy

  • Post-marketing and life cycle management strategies

  • Consultations with regulatory bodies

  • Evaluation of documentation against existing rules and regulations

  • Preparing country specific dossiers

REGULATORY INTELLIGENCE

knowledge and experience in regulatory affairs

  • Interpretation of national requirements

  • Information on country-specific requirements

  • Screening regulatory authority websites

  • Search and analysis services on request and as required

  • Seeking, analyzing and archiving directives and other relevant documents

MARKETING AUTHORIZATION

PROCEDURES

country specific regulatory support in Hungary

  • Organization for application slots

  • Gap analyses of existing documentation, updating and adjustment

  • Compilation of submission dossiers

  • Assistance with marketing authorisation applications in Hungary (national, MR or DC procedures)

  • Agency consultations, requesting scientific advice

  • Submission process

  • Shipment of all documents to the authorities

  • Correspondence with Hungarian authorities

  • Management of marketing authorisation procedures

  • Management of the national phase of MR/DC procedures

LABELING

precision and accuracy in translation and preparation of product information

  • Preparation of SPCs, patient information and labeling

  • Translations of SPCs, labeling texts and package leaflets into Hungarian

  • Update of SPCs, labeling texts and package leaflets/PILs in compliance with European and national requirements

  • Implementation of requirements requested by the customer/the authorities

  • Amendment of content when required by the authorities

  • Evaluation of inner/outer packaging and artworks

  • Originator adaptations

  • QRD adaptation

  • Linguistic review

 

LIFE CYCLE MANAGEMENT

scheduled and timely actions during the whole lifecycle

  • Lifecycle management

  • Advice on data requirements for variations and variation classification

  • Compilation of country-specific requirements

  • Correspondence with Hungarian authorities

  • Preparation, submission and managing of variations, renewals and MAH transfer applications

 

REGULATORY COMPLIANCE

  • Regulatory Compliance Management

  • Review of labels and leaflets (artworks)

  • Review of advertising and promotional materials against legal requirements

  • Promotional material sign-off

  • Translation of Direct Healthcare Professional Communication

  • Translation and submission of Risk minimization tools

MEDICAL DEVICES

localization / translation

  • Preparation of IFUs for medical devices

  • Preparation of labeling for medical devices

  • Evaluation of artworks

  • IFU translation

FOOD

food supplements / dietary foods
/ food for special medical purposes

  • Preparation of labeling

  • Notification of food supplements and special foods

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