Our offering

NCEs

"We support our customers from the initial stages of development to the manufacturing of commercial quantities of APIs, intermediates thereof, and pharmaceutical intermediates".

Our Core Team system establishes the involvement of all relevant staff as of the early stages of the project (from R&D/Manufacturing/Quality to EHS/Procurement), addresses all potential roadblocks in your project, and proposes long-term solutions.


 

Our proactive staff has been involved in more than 20 NCE customer filings since 2007, with an outstanding success rate (all projects were approved by authorities without any setback related to the manufacturing of the drug substance).

Our Experience: Supporting Customers with their NCE Filings


  Therapeutic Category Company Markets
2007 Quinolone Japanese Company Japan
2010 Antihypertensive Japanese Company Worldwide
2011 Anticancer
Antigout
Big Pharma Company
Japanese Company
Worldwide
2011-2013 Antiretroviral
Cystic Fibrosis Therapy
US Biotech Worldwide
2014 Antiretroviral
Cystic Fibrosis Therapy
Antihypertensive
US Biotech
 
Japanese Company
Worldwide
 
Japan
2015 Antiretroviral US Biotech Worldwide
2016 Antipsoriasis US Biotech Worldwide
2017 Antiretroviral
Anticancer
Cystic Fibrosis Therapy
2 US Biotechs Worldwide
2018 Antiretroviral US Biotech Worldwide
2019 CKD Anemia
Anticancer
Hematologic Malignancies
Cystic Fibrosis Therapy (2)
3 US and 1 Japanese Biotech Japan
USA
USA
USA
2020 CDA Inhibitor Japanese Company Worldwide
2022 Antiviral
Anticancer
Global Pharma
Japanese Company
Worldwide
USA

 

23 NCE's FILINGS 2007-2022 (including submitted with pending authorization)

Our people's strong involvement in the projects and our policy to have a low number of new customers per year (not more than two customers per year are usually added) allows full dedication to your project.

Process development

Process development

Our Global R&D Department is responsible for the industry-oriented Process Development of all new products, and has capability to support the industrialization of these products in the three continents.



Simultaneous chemical and analytical development, scale-up under cGMPs, and transfer and validation services, are provided. Core teams are set up for all incoming projects, from evaluation to validation. Business Development and Regulatory are also involved during the entire development process


"New Development Concepts", such as PAR, QbD, DoE, process simulation, etc., are taken into account during development, with special attention paid to the solid form of the final API (particle size, polymorphism...).


Our R&D team also supports product validation and industrialization by preparing QRAs, HAZOPs, etc.


Since 2007 the R&D team has been involved in more than 20 NCE customer projects carried out through commercial manufacturing.

Project management system

It is known that one of the factors of success of a project lies on effective communication between all participants.


We at Esteve Química decided to establish Core Teams to manage our projects more effectively. These Core Teams are inter-disciplinary groups, established at the inception of the project, that follow the project throughout its life, from lab trials, scale-up and validation to marketing.


Core Teams are composed of people from R&D, manufacturing, quality, EHS and purchasing, thus allowing addressing all potential roadblocks in the project and proposing long-term solutions.


Technical communication with the client is assured through the Core Team Leader figure, with regular meetings (teleconference, face to face…) held to meet customer needs and solve problems fast.


More info Here

Project management system