IR PHARMA CONSULTING

IR Pharma Consulting is specialized in Product Management Services (DS & DP), Technical Support for the Pharmaceutical, Biotech and Medical Device Industries. Services include product development, quality and regulatory compliance, life science products launches , manufacturing and supply management, strategic programs implementation and support in investment decisions. * Product development (DS & DP) Formulation development and scale up : 25 years of experience in oral , topical and parenteral small and large molecules dosage forms. Support to route of administration selection, choice of excipients, preformulation and formulation optimizations. Process development and optimization, QbD and PAT. Support to analytical development (analytical method development , stability trouble shooting) * Product life cycle management (line extension, new formulation, generic, OTC,…) * CMC regulatory Support to product development strategy/ product approval CTD Module 3 & IMPD writing * Clinical trial material supply Management Clinical Demand and Supply Selection of manufacturing partner for phases I to III and product launch. * Product and Technology Transfers Assistance to manufacturing process transfer at recieving site(s) Implementation of new manufacturing technology and processes at manafacturing & supply partner’s sites * QMS audit * CDMO selection Technical due diligences acccording to technical/ commercial needs and key attributes Technology Transfer to a Contract Development and Manufacturing Organization * Operational Excellence Diagnostics, change management plan & implementation * Merger & Acquisition supports Business strategy Support in investment decisions Technical due diligences . Patents : more than 25 patents in formulation and process fields (oral, topical, transdermal,...) Last patent applications : co inventor of UV filters long lasting protection owned and developed by Skinosive Global Rising Star InCos award 2024

Secteur

Fabrication de produits pharmaceutiques

Taille de l’entreprise

1 employé

Siège social

Gâvres, Brittany

Type

Société civile/Société commerciale/Autres types de sociétés

Fondée en

2018

Domaines

Product development , Oral, topical, transdermal, parenteral formulations, Process design, Product transfers, CDMO selection, Mergers and Acquisitions support, GMP , Operational excellence/ Change management, Training, Medical Devices, CDMO management, Support investment decisions, Technical due diligences et Cosmetic formulations