Medicinal products
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Drawing up/assessing protocols of clinical trials, expert opinions for control authorities
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Use of the main search engines for scientific publications
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Preparation of Module 1, Module 2, Module 3, Module 4, Module 5 to request new AIC in CTD-eCTD and NeeS
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Herbal medicines
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Homeopathic medicines
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Assistance to obtain authorization to produce and market narcotic drugs
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Type I and Type II Renewals and Variations
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Transfers of ownership
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Quality Expert Statements
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Formatting the dossier from NTA to CTD format, e-CTD and Nees
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Due diligence e gap analysis
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Drafting and translation of SPCs, labels and leaflets
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Operative procedures
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Production methods
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Assistance in preparing the documents required for performing Scientific Advice
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Transfers of ownership
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Medicinal product price assessment in the development or acquisition stage
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Preparation of dossiers for price negotiation
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Market and competition analysis
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Economic assessment of therapies by determining the cost/effectiveness, cost/usefulness and cost/benefit ratio
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Economic assessments for regulatory purposes (pre-marketing assessment)
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Market Access and support to price negotiation (medicinal product-economy)
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Analysis of the business organization, institution of service, formation of the Head of Service and his collaborators
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Assume the role of the European Qualified Person for Pharmacovigilance(EU-QPPV) with availability H24 / 365 days a year
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Assume the role of Deputy Head of Pharmacovigilance EU-QPPV-Deputy
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Assume the role of Quality Assurance of pharmacovigilance
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Assume the role of Contact Local Point
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Daily access to the National Pharmacovigilance Network (for medicinal / active ingredient and maintaining track access)
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Preparation and maintenance of the management manual of the Pharmacovigilance System
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Preparation, maintenance and updating the Pharmacovigilance System Master File (PSMF) and its summary (Mod.1.8.1) or redaction of PSMF, already in-house, to the new system of pharmacovigilance
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Preparation and updating of Risk Management Plan (RMN), (Mod.1.8.2) if applicable
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Registration to Eudravigilance
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Insertion and update of medicinal products in Eudravigilance
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Preparation and updating of Standard Operating Procedures (SOPs) and of the Working Instruction
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Registration, in paper and electronic register, and evaluation of national and foreign ADR
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Weekly inspection of national and international safety scientific literature (including a report of the activities)
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Preparation of corporate bill books for the writing of PSURs
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Preparation of Periodic Safety Update Reports (PSURs) according to current regulations
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Assessment of new “Signals” and evaluation of medicinal products risk / benefit assessment
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Adverse reactions reports management (Adverse Drug Reaction) in collaboration with the Medical Director
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Medical evaluation of every reports, for which it is not possible to exclude the ownership, for active ingredient, medicinal product and scientific literature
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Indictment and evaluation of data concerning reports received (encoding MedDRA, case ‘s follow-up, assigning internal code, assessment of causality and of the presence of the reaction in the SPC – listedness – of severity and of medical importance, clinical evaluation) and its inclusion in the electronic register
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Semi-annual or annual Signal Detection
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Pharmacovigilance Training (pharmaceutical sales representatives and / or company personnel)
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Annual updates of the training
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Audit of Pharmacovigilance (internal and external)
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Management of CAPA
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Assistance for issuing certificates of Pharmaceutical Products (CPP) registered in Italy
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Assistance for issuing export certificates (medicinal products produced in Italy, without AIC)
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Assistance for issuing GMP certificates
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Documents legalization at embassies or consulates
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Sworn translations
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Import/Export Permits
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Business potential assessment, new business and improvement areas finding, mature products evaluation in search of new application in combination or with new indications
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Preparation of the documentation for PMC registration (according to the Provv. 5/2/1999)
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Variations to the authorisations of already registered PMC
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Contacts with authorised analysis laboratories to draw up the registration documentation: identification of the active substance/substances, stability analysis and effectiveness assessment in compliance with EN standards
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Assistance with the preparation and submission of the registration dossier to the competent Authorities: Istituto Superiore di Sanità and the Ministry of Health
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Assistance in obtaining authorisations to health advertising and issuance of free sale certificates (FSC)
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Technical-scientific translations (including sworn translations)
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Preparation of biocidal product authorization dossier (according to Reg. UE 528/2012 and subsequent amendments)
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Assessment of the formula and regulatory framework according to product type
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Verification of the inclusion of the active substance present in the formulation in the approved list or in the review program
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Follow-up of the active substance approval procedure in accordance with BPR (Working Group, Biocidal Products Committee and final approval)
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Planning of efficacy, stability analyses, chemical and physical tests, environmental-toxicological analyses and checks, in cooperation with GLP certified analysis laboratories and according to risk assessment
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Assessment and preparation of the documentation in order to prepare the technical files for the application of biocide and biocidal product family authorization
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Assessment and preparation of labelling on the basis of in force regulations. Translation of label texts in the required languages
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Operations with the IUCLID software to send information on chemicals and biocidal products to the European Chemicals Agency (ECHA)
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Operations with the SPC editor to prepare the Summary of Product Characteristics
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Operations with the R4BP3 register, to submit biocidal product dossiers
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Mutual recognitions
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Variations (administrative, minor and major changes) to already authorized biocidal products
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Assistance with the National Authorities (Ministry of Health and Istituto Superiore di Sanità) until obtaining the authorization decree
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Product assessment, intended use, mechanism of action and classification
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Identification of tests required to support the intended use, safety and effectiveness of the device and their assessment
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Clinical bibliographic evaluation or documents preparation for clinical study authorization applying
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Identification and relations with manufatcuring plans for device’s technical documentation
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Preparation of the Technical files pursuant to directive 93/42 and 98/79 EEC as amended and risk assessment pursuant to the reference standard for device certification
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Relations with Notified Bodies for device CE marking
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On-line notifications in the database of the Ministry of Health
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Assistance in obtaining authorizations to advertising and issuance of certificates of free sale
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Qualification of suppliers and assistance in the audit stage
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Contacts with specialized laboratories and clinical centers
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Management of projects for designing, developing, engineering, testing and certification of the device according to the client’s requests
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Requests for free sale certificates
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Import of plasma and human serum
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Preliminary assessment of the formulations and contents of label information in relation to their compliance with current regulations
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Research and feasibility on the claims attributable to the various product categories
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Food regulations, nutrition and health indications, food additives, specific warnings
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Notification procedures to the Ministry of Health and product follow-up
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Assistance in issuance of Free Sale certificates (FSC)
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Assessment and review of advertisements and information material
Cosmetics
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Assistance on the verification of formulations and single ingredients compliance with applicable regulations
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Preliminary examination of labels and claims in compliance with the in force regulations
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Centralised European notification (Reg. EU No. 1223/2009)
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Preparation of the Product Information File (PIF)
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Preparation and signature of the “Safety Assessment” by a responsible expert in compliance with the regulation
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Supplier evaluation and audits conducted by specialized technicians at manufacturing companies to verify the quality and compliance with cosmetic GMPs
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Assistance and preparation of applications for Free Sale Certificates (FSC) for use in countries outside the European Union
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Apostille and Legalization services of the FSC at consulates and embassies
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Preliminary assessment of advertising campaigns texts
Veterinary medicinal products
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Advice and preparation of applications for marketing authorizations for national, mutual recognition and decentralized procedures.
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Elaboration of dossiers in the European format NTA vol. 6B, in all its parts
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Preparation of renewals, type IA, type IB and Type II variations, transfers of ownership
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Quality Expert Statements
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Standard Operating Procedures
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Drafting and translation of SPCs, labels and leaflets
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Requests for free sale certificates
Dangerous preparations notification in the database
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Entering data into Istituto Superiore di Sanità database of Hazardous Preparations such as medical devices, presidi medico-chirurgici, biocides, detergents and mixtures
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