Regulatory affairs of medical devices, food supplements, cosmetic, biocides

REGULATORY AFFAIRS OF MEDICAL DEVICES:

• consultations regarding the introduction of medical devices into the market: competitive and regulatory environment;
• preparation of medical device files according the EU legal requirements;
• medical device notification: application completion and submission to the State Health Care Accreditation Agency under the Ministry of Health, representation in dealing with the Agency;
• organization and coordination of CE certification / conformity assessment for medical devices: preparation of an action plan, finding a notified body of the European Community and agreement on actions, coordination of the action plan between the notified body and the client;
• collection, handling, and evaluation of information about incidents related to medical devices, referrals to national authorities.

REGULATORY AFFAIRS OF FOOD SUPPLEMENTS:

• presentation of information about the requirements of the legislation of the Republic of Lithuania and the EU;
• preparation of food supplement labelling and other required documentation;
• collection of scientific information about food supplements;
• analysis and assessment of food supplement labelling, prepared by the client, advice on information presentation;
• notification of food supplements: filling in of notification forms and submission to the National Food and Veterinary Risk Assessment Institute, representation in dealing with the Authority;
• services in registration of food supplements in other EU countries such as Latvia, Estonia, Poland, Bulgaria, Czech Republic, Slovak Republic.

REGULATORY AFFAIRS OF COSMETIC PRODUCTS:

• presentation of information about the requirements of the legislation of the Republic of Lithuania and the EU;
• preparation of the cosmetic product information files;
• preparation of cosmetic product labelling and collection of scientific information;
• analysis and assessment of cosmetic product labeling, prepared by the client, advice on information presentation;
• notification of cosmetic products: submitting, by electronic means (through Cosmetic Product Notification Portal (CPNP)), the notification to the European Commission, representation in dealing with the Competent Authorities;
• cosmetic product safety assessment, preparation of the cosmetic product safety reports.

REGULATORY AFFAIRS OF BIOCIDAL PRODUCTS:

• presentation of information about the requirements of the legislation of the Republic of Lithuania and the EU;
• preparation of dossiers of biocidal active substances and products, organization and coordination of necessary studies;
• preparation of biocidal product label and instructions for use;
• biocidal product authorization / regulatory affairs: completion of applications for authorisation or registration of biocidal products, collection of all necessary documents and presentation to the State Public Health Service under the Ministry of Health, representation in dealing with the Service.