DISCOVER THE NEW REIG JOFRE

DISCOVER THE NEW REIG JOFRE

Its specialized production strength and its experience in international regulatory processes, allow the company to license new pharmaceutical products, generics and modified generics throughout the five continents under long-term production agreements.

Reig Jofre works as a team and in close collaboration with its customers from initial product development to stability studies, the manufacturing of preclinical batches, quality control and assurance, compliance with regulatory requirements and the validation of commercial batches.

Regulatory services

Reig Jofre has an extensive experience in the regulatory field on a worldwide level, and especially in Europe and USA.

 

Preparation of registration dossiers in EU and non-EU countries in SENs and e-CTD formats using specific software.

 

Experience in registration processes in Europe, via domestic mutual recognition or decentralized procedures.

Regulatory support, from the presentation of the registration to the approval of the drug by answering the allegations requested by the various regulatory authorities, including post-approval regulatory work, such as presenting variations or renewals. Possibility to design the development of third-parties products according to ICH Q8 standards and prepare the presentation of the application for the commercialization authorization.

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With proven experience and a solid scientific focus, Reig Jofre specializes in the stabilization of active ingredients for the manufacture of injectable lyophilized products, as well as in the design and development of release systems to improve the effectiveness of bio-molecules.

 

Reig Jofre has an extensive list of dossiers that can be licensed for marketing in international markets, ensuring excellent and recognized quality in all processes, personalized service and a reliable supply with long-term competitive prices.

Dermatology

  • Anaclosil
  • Medebiotin
  • Complidermol
  • Complidermol 5 α
  • Deripil
  • Tri-Hachemina
  • Medetopic
  • Mede H
  • Ony-tec
Producto

Gynecology

  • Nife-par
  • GynEC DX
  • Pre-par
  • Orvangel
  • Medebiotin
Producto

Respiratory

  • Pulmictan
  • Budesonida
  • Easyhaler
  • Blox Allergy
Producto

Antibiotics

  • Ardine
  • ArdineClav
  • Britapen
  • Farmaproina
  • Benzetacil
  • Benoral
  • Citrocil
Producto

Consumer Healthcare

  • Lacteol
  • Otocerum
  • Vaselina Orravan
  • Phonal
  • Amniolina
  • Amnioplus H2O
  • desinfectants
Producto
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