PMC Isochem Quality system:
- delivers the right quality to the right need in full compliance with regulatory requirement
- is based on a long experience working according to the Pharmaceutical Industry and other markets guidance
- complies with internal policies as well as international standards ISO and cGMP (Q7).
The 4 pillars of our Quality Policy:
- Regulatory compliance
- Management Information System
- Continuous Improvement
- Committed personnel
Our certifications
| Certifications | Gennevilliers | Pithiviers | Vert-Le-Petit |
|---|---|---|---|
| ISO 9001:2015 | ♦ | ♦ | ♦ |
| cGMP (Q7) | ♦ | ♦ | ♦ |
| Inspected by FDA | ♦ | ♦ | ♦ |
| ISO 14001 | | ♦ | |
Regulatory
PMC Isochem offers full regulatory support such as registration of new substances through IND or ASMF/DMF filing.
More than 35 ASMF/DMF and CEP have been filed by PMC Isochem in different countries.
See below our active Generic Files :
| Product | DMS/ASMF | CEP | Country |
|---|---|---|---|
| 1,3,5-Trimethoxybenzene | ♦ | | Italy |
| Acetohydroxamic acid | ♦ | | USA, Spain |
| Amiodarone hydrochloride | ♦ | ♦ | Australia, Canada, Europe, USA |
| Domiphen bromide | ♦ | | UK, USA |
| Econazole nitrate | ♦ | | Europe |
| Indoramine hydrochloride | ♦ | | Ireland, UK, USA |
| Loperamide hydrochloride | ♦ | | Canada, France, USA |
| Naftazone | ♦ | | Belgium, France, Switzerland |
| Nefopam hydrochloride | ♦ | | Canada, France, Ireland, UK, USA |
| Pantoprazole sodium sesquihydrate | ♦ | ♦ | Europe, USA |
| Tertiobutylchlorobutyrophenone | ♦ | | USA |
| Tocofersolan ( Vit. E TPGS ) | ♦ | Europe, USA | |
| Trimebutine base | ♦ | | France |
| Trimebutine maleate | ♦ | ♦ | Canada, Europe, France, Italy, USA |
REACH
« One of the main objectives of REACH Regulation is to increase and promote innovation by providing encouragement to innovate for research-orientated companies » (From ECHA November 2014 – Guidance on Scientific R&D (SR&D) and Product and Process Orientated Research and Development (PPORD)).
Deeply involved in REACH Regulation, PMC Isochem has about 60 registrations and manages close relationship with its cutomers and suppliers to ensure a reliable supply chain.
In cooperation with France Chimie and SICOS councils, PMC Isochem also notifies intermediates manufactured under strictly controlled conditions for the protection of workers and the environment.