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Welcome to Regulatop!

Regulatop was born after 20 years of exposure to the restless European Pharmaceutical Regulatory environment. Cinzia Boldarino, founder and owner, is a Biochemist keen on matching Regulations with the Pharmaceutical Business challenges.

We are proud to contribute to patients' health

REGULATORY AFFAIRS

"Always do more than is required of you"

- George S. Patton -

OUR SERVICES

Regulatory support is provided on Drug Products (Human and Veterinary), Medical Devices, Food Supplements and Food for Special Medical Purposes.


Human and Veterinary medicinal products

  • Marketing Authorization submission strategy in complex scenarios
  • MA submission feasibility studies
  • Due diligence and strategic support on companies/portfolio acquisition
  • Due diligence on registration dossiers modules
  • Marketing Authorization submissions, Variations and Renewals (for Decentralized/MR and National procedures) and maintenance
  • Full CMC expertise, human and veterinary, EU
  • Technical writing (module 2.3 and module 3, IMPD)
  • Medical writing (modules 2.4, 2.5, 2.6, 2.7 and translations IT-EN and EN-IT)
  • Product Information writing
  • Start-up of a pharma company (Italy)
  • Full regulatory support on Italian Marketing Authorizations:
  • SIS code and Company Users Administrator (AUA) applications
  • Proxy towards AIFA
  • Digital domicile and certified email
  • Local Representative and (Concessionario) notifications
  • eCTD publishing
  • Marketing Authorization tranfers
  • Marketing Authorization revocation
  • AIFA FrontEnd portal access / management
  • EiDAS compliant digital signature - recognized on FrontEnd
  • Promotional materials and Scientific Information Services
  • Congresses
  • Local mandatory databanks (Farmastampati, Unifarm (Bozen) and commercial databanks
  • Local OJ publication
  • Falsified Medicines related tasks
  • CPP request (Certificate of Pharmaceutical Product)
  • Price and Reimbursement (in partnership with local experts)
  • Advice on Regulatory department organization
  • Regulatory Intelligence
  • Narcotics import requests
  • Sunset Clause
  • Shortage management
  • Scientific advice
  • Pre-submission meeting (AIFA)

    • Medical Devices

  • Proxy towards Italian Ministry of Health
  • Support from feasibility analysis to CE marking
  • Italian Ministry of Health MD databank: registration and maintenance
  • Promotion on Medical Devices: set-up, review, submission till approval
  • Congresses

    • Food Supplement and Food for Special Medical Purposes

  • Notification onto Ministry of Health Food Supplements databank
  • Free sale certificates

    • PHARMACOVIGILANCE

    "Don't find fault. Find a remedy."

    - Henry Ford, Founder Ford Motor Company -

    OUR SERVICES

    Pharmacovigilance Support is provided under Regulatop's or Marketing Authorization Holder's quality system.


    Medicinal products

  • Setup of Pharmacovigilance Quality System for the Marketing Authorization Holder of a medicinal product
  • EU QPPV and Deputy services
  • Writing Safety documents: Standard Operating Procedures, Pharmacovigilance System Master File, Periodic Safety Update Report, Safety Data Exchange Agreements, Pharmacovigilance Agreements, Risk Management Plan and setup of Risk Minimization Measures
  • Covering internal Company’s roles ad interim e.g. Local Safety Officer and Deputy
  • Pharmacovigilance - Italy:
  • Local contact of pharmacovigilance
  • Local Literature Screening
  • Educational Materials setup, submission, dissemination
  • Writing Direct Healthcare Professional Communications
  • Pharmacovigilance for homeopathic products

    • Medical Devices

  • Vigilance and Surveillance tasks related to Medical Devices (Italy)

    • Other

  • NutriVigilance
  • CosmetoVigilance
  • Submission of Adverse Events onto databank Vigierbe

    • QUALITY ASSURANCE

    "Give them quality. That's the best kind of advertising."

    - Milton Hersey -

    OUR SERVICES

  • Local QA support to the Marketing Authorization Holder (GDP and GVP):
  • Covering the role of Local QA Officer
  • Drafting GxP documentation (Policies, Standard Operating Procedures, working instructions, manuals...)
  • Managing local medicines Shortage/Import permit/Recalls
  • Setting-up a GDP and GVP Quality System
  • Auditing (GDP) for both medicinal products and Medical Devices

    • TRAINING COURSES

    "Education is the most powerful weapon which you can use to change the world."

    - Nelson Mandela -

    OUR SERVICES

    Regulatop provides training courses (on site and remotely):


  • Individual tailored training on general GXP and specific Regulatory, Pharmacovigilance, Quality topics
  • Company training on Regulatory, Pharmacovigilance, Quality topics, e.g.:
  • GDP, Pharmacovigilance training to local employees, Sales Force
  • Pharmacovigilance operational tasks

    • Download our brochure


    About Us

    OUR TEAM

    "A man without a smiling face must not open a shop"

    - Chinese proverb -

    Our team hosts seasoned experts together with younger profiles.

    With this mix of energy and experience, we can follow projects in a very prompt, tailored and accurate way.

    Furthermore, we benefit from an extensive net of professionals all over the globe to keep on track of legislation updates and best practices on a variety of fields.

    ORGANIZATION CHART

    WHAT THEY SAY ABOUT US

    "One kind word can warm three winter months"

    - Japanese Proverb -



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    Where to find us

    Office

    Via F. Baracca, 10

    20017 Rho (MI)

    Italy

    Feel free to contact us with the below box either to request information or to get a quotation.
    Reply is guaranteed as soon as possible.

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