SKILLPHARMA
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Regulatory Affairs

The proper management of the regulatory activities is crucial to achieve the business goals of the health sector companies.

Thanks to its long-standing multidisciplinary experience, SKILLPHARMA supports effectively its Customers in obtaining and maintaining all the necessary authorizations for marketing their pharmaceutical products, minimizing the times required.

The marked attention to concreteness and high quality results, the deep knowledge of normative, the prime importance acknowledged to the professional updating distinguish all our team and guarantee the strong competitive advantages to our Customers, for the strategic activities management and for all the operational steps relating the whole products lifecycle.

Our services include:

Human-Use Medicinal Products

  • marketing authorization application for human-use medicine products by means of decentralized, mutual recognition or national procedures, including registration of Traditional Herbal Medicines
  • review of technical documentation relative to drug substance (chemical, biological) / drug products in conformity with national and/or European requirements
  • preparation and submission of MA variation applications (type IA/IB, type II, Line extension), MAH ownership transfers and MA renewals
  • review and managing of dispensing/classification switches
  • preparation and submission of Pediatric Investigation Plan
  • assistance for documental and procedural managing for SIS code obtaining for Italian and foreign companies
  • preparation of practice for price negotiation & reimbursement
  • preparation of Quality Expert Reports
  • managing of CMC (Chemistry, Manufacturing & Control) Review projects
  • development of Common Technical Documentation (CTD)
  • conversion of paper or NEES documents into electronic dossiers using e-CTD (electronic Common Technical Document) software/eCTD compilation and publishing
  • assistance and monitoring of the authorization procedures at Italian and European regulatory authorities till their successful completion

Veterinary Medicinal Products

  • marketing authorization application for veterinary medicine products by means of decentralized, mutual recognition or national procedures
  • review of technical documentation relative to drug substance (chemical, biological) / drug products in conformity with national and/or European requirements
  • preparation and submission of MA variation applications (type IA/IB, type II, Line extension), MAH ownership transfer and MA renewal
  • preparation of Quality Expert Reports
  • managing of CMC (Chemistry, Manufacturing & Control) Review projects
  • preparation and review of labeling
  • assistance and monitoring of the authorization procedures at Italian and European regulatory authorities till their successful completion

Manufacturing Sites

  • obtaining of authorizations for managing of narcotic and psychotropic substances
  • obtaining, maintaining and renewal of manufacturing authorizations for active substances/drugs
  • preparation of administrative changes to manufacturing authorizations/ managing of narcotic and psychotropic substances
  • preparation of requests for QP appropriateness recognition and managing of documental procedure till the authorization obtainment
  • managing of import/export authorizations - CPP, CLV, GMP, import/export certificates for narcotic and psychotropic substances, documented self-certification: request, certificate obtaining and legalization
  • preparation and/or review, first submission and subsequent revision submission of Active Substance Master File (ASMF)

Medical Devices

  • classification
  • preparation and/o revision of Technical File
  • certification process support and managing to obtain the CE mark at the Notified Body
  • support and managing of the notification at health authorities in European countries
  • notification of manufacturers, medical devices (MD) and in-vitro diagnostic devices (IVD) into the Ministry of Health database

Cosmetics

  • classification
  • regulatory review of Health Claims
  • preparation and/or revision of cosmetics dossier (Product Information File)
  • preparation and review of labeling
  • CPNP notification
  • request for Free Sale Certificates (CLVs)

Food / Food Supplements / Dietary Foods / Food For Special Medical Purposes

  • classification
  • regulatory review of dietary claims
  • review of a new product composition compliance: raw materials and dosages
  • formulation conformity review
  • preparation and/or review of labeling
  • notification of applications at the Ministry of Health

Biocides/ Medical -Surgical Devices (Pmc)

  • classification
  • preparation and/or revision of technical documentation
  • preparation and/or review of labeling
  • request for Free Sale Certificates (CLVs) for PMC
  • notification of applications

Borderline Products

  • classification according to the current regulations
  • preparation and notification procedures