Keypharma - Problem Solving Keys

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MY REQUEST:

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We may from time to contact you by e-mail or post with information about our products, services or promotional/marketing initiatives that may be of interest to you. If you do not wish to receive such details you can easily opt-out of receiving further information from us by clicking the button underneath (please read our “Privacy Notice” below).

I do not authorize KEYPHARMA S.r.l. to store my data given above and to use them for the purposes described above.

PRIVACY NOTICE -
The information provided by the applicant will be used by Keypharma s.r.l. ('Keypharma'), owner of the relevant website and domain, for the sole purpose of understanding better your needs and interests and providing you with better service and/or following the procedures deemed necessary to respond to your request. With your consent, Keypharma will periodically access your data filed in its archives in order to inform you of its products and the promotional/marketing initiatives Keypharma is conducting on behalf of its clients, unless otherwise agreed by the relevant applicant. -
Data collection will be made in compliance with Legislative Decree No 196/2003 (containing the “Personal Data Protection Code”) as subsequently amended and supplemented. Information provided under article 13 of Legislative Decree 196/03 – Please be informed that the treatment of your personal data will be performed with the utmost care, diligence and accuracy as to guarantee the confidentiality of the data provided and, in general, all rights pertaining to the applicants. You are also aware that according to article 7 of Legislative Decree 196/03, you have the right to visualize your data at any time, object to their use, submit an updated version, or correct the data by contacting us directly: E-mail, info@keypharma.it; Address, Keypharma S.r.l. Corso di Porta Romana, 72, 20122 Milan, Italy; Telephone, ++39 02 58318521; Fax, ++39 02 58318583.

The compilation of your data in this form and the receipt of this e-mail implies your approval and consensus to all described above.

Our Services

Experience,
punctuality,
service customization

Regulatory Affairs

Our Regulatory Affairs Services cover a wide variety of different areas thus helping companies across the pharma and related industry sectors in managing day-to-day regulatory affairs as well as additional activities that require specific competencies or additional resources.

These activities can be partially or fully outsourced both on- and off-site.

The primary services provided in this area include:

Preparation and submission of Marketing Authorization Applications (Centralized Procedures, DCP, MRP, National Procedures)
Preparation and submission of Variations (Type I – II), Switch (POM ->OTC), Renewals
Preparation, submission and follow-up of Scientific Advice and Orphan Drug Designations
Life-cycle management in partial or total outsourcing
Technical Writing: Modules 3 and 2.3, Active Substance Master File (ASMF) or Drug Master File (DMF) preparation
Reviews and updating of approved dossiers, regulatory/quality gap analysis, CTD conversions
Regulatory compliance (GLP, GMP, GCP)
eSubmission services (eCTD, NeeS)
Legal and administrative representation of foreign companies operating in Italy
Start-up assistance
Due Diligence of regulatory dossiers within acquisition projects of companies or products
PIL user testing
Compliance check of labelling, congresses, promotional materials, websites
Liaison with the Authorities
Consulting services for Pricing & Reimbursement activities (P&R dossiers, pricing strategies, planning and coordination of pharmacoeconomic studies, assistance in negotiations)
Medical Devices and Neutraceuticals (development and regulatory assistance)
Scientific and technical translations.

Newsroom

EC: information to patients and Pharmacovigilance - New developments

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