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Regulatory Affairs
Always providing industry leading support at every step of the product lifecycle

We have gained a broad experience both in active substance and in a wide range of pharmaceutical forms:

  • oral (solid and liquid dosage forms)
  • topical (semi solid or liquid dosage forms, including patches) 
  • injectable (including freeze-dried) dosage forms
  • medicinal gas
  • radiopharmaceuticals

and types of products:

  • Innovative (chemical and biological)
  • Generics
  • EU Hybrids
  • Well-established use
  • Herbal
  • Homeopatic

CMC strategy and documentation plays an important role from early development (IMP dossier) to the marketing authorization application dossier, in close connection with the regulatory strategy and the goal of the Company.

Pharma D&S consistently provide the best support for your products while making sure to comply to regulatory requirements.

Pharma D&S can provide  both a fully integrated support (from lab to market) or a support based on your specific needs, at any stage of development as well as during the post-approval lifecycle of Human Medicinal Products.


Each new beginning is important: selecting the most effective regulatory strategy right from the research and development phase, allows us to support companies dealing with complex regulations.

  • Identification of CMO, support for formulation development, process characterization, method / process validation, stability studies
  • Development strategy and Roadmaps – Integrated with Non-clinical & Clinical development, including assessment of feasibility, strategy, timelines and costs
  • Scientific advice and Health Agency meetings, including preparation and submission of briefing documents, development of company presentations, representing or supporting the company during meetings
  • Gap analysis
  • Comparability exercises
  • EU IMPD – writing, review and/or updates
  • Dossier for pharmaceutical products writing, review and/or update (ICH/non-ICH)
  • Preparing, writing and updating EU ASMF
  • Collect, write and update documentation to obtain the “Certificate of Suitability” to the monographs of the European Pharmacopoeia (CEP)
  • Scientific, Regulatory and Technical writing, Expert Reports
  • Ad-hoc regulatory strategy

The competence you can trust for the compliance you need. Always delivering: quality, efficacy and product safety are key to define the best strategy and ensure prompt marketing authorization and commercialization.

  • CTD (Common technical Document) writing, review and/or updates for registration procedures, including expert’s signature
  • Expert support on responses to Deficiency Letters
  • Expert Reports
  • Readability tests for all types of EU registration procedures
  • Management of translation (CP; CDP; MRP; NP)
  • Comprehensive eCTD services: compilation, publishing
  • Analyse and evaluate regulatory and reimbursement strategy
pharma d&s regulatory affairs

The support you have always been looking for managing the complexity, unpredictability and intensity of the critical post-approval phase.

  • CMC regulatory strategy
  • Regulatory compliance gap analysis
  • Updating dossier sections – strategy, writing and review
  • Variations/renewals/notifications – strategy, writing, review and/or update of dossier
  • Switching a prescription (Rx) product to over-the-counter (OTC) status
  • Expert support on responses to Deficiency Letters
  • Expert Reports (including updates) including expert’s signature
  • Updated dossier that reflects the state of the art of the product (consolidated dossier)
  • Ad-hoc regulatory strategy
  • Comprehensive eCTD services: full life-cycle support for Europe

Pharma D&S is a global service provider, but we are acquired local expertise in Italy during the last 15 years.

Our experts have extensive experience with official local Italian entities such as the AIFA, the Ministry of Health, Istituto Superiore di Sanità, among others. We are fully up to date with local requirements and news.

We can assist you with comprehensive local activities, supported by a platform and hub model that leverages regulatory knowledge, science service, clinical and pharmacovigilance expertise while ensuring local support for country-specific procedures.

In particular, we can support you on:

  • Request of the ID code issued by AIFA to all pharma companies (SIS code)
  • Management of Italian AIFA’s portals and databases (e.g. front-end)
  • Management of Italian database for IVD
  • Mandatory activities before launching
  • MA Transfers
  • Specific annual mandatory activities for maintenance of MA
  • Local variations and renewals of National MA
  • Price increase application
  • Compassionate use medicines management
  • Name patient program
  • Translation and implementation of RMP
  • Clinical Trial Applications and substantial amendments in Italy
  • Continuous update on changes of local requirements
  • Artwork management
  • Farmastampati
  • Farmarete (bilinguism Italian/German language)
  • Bollino management and traceability
  • Free sales certificate
  • Management of publication on Italian Gazette
  • Competitive intelligence
  • Drug authorization and permits according to DPR 309/90
  • Power of attorney to manage relationship with AIFA/MinSal/ISS
  • Act as “Responsabile del Servizio Scientifico” in Italy
  • Management the Italian requirement for ISF
  • Management the submission of the promotional materials to AIFA/MinSal
  • Management the submission of the congress’ request to AIFA
  • Translations of texts and labels
  • “Farmindustria certification”.