Quality management and specific GMP consultation

 

Working in a regulated environment like the Life Science industry is frequently characterized by verification of multiple specific documents. It often takes a lot of time to prepare these documents. Sometimes, the extent isn’t apparent or one has become “professionally blinkered”. A fresh breeze in the form of external input is a good choice in this case. We want to support you on an individual basis as a support provider in the fields of quality management (ISO 13485 and ISO 17025) and selected GMP topics, ranging from an “external look” (internal audits according to ISO 13485 and ISO 17025 fall within this area) and a comprehensive consultation to preparing the necessary documents completely. We comply with your needs and develop a solution together with you that is tailored to your request.

 

We'd like to present our services to you in detail on the following pages:

Method validation

Method transfer

Filter validation

Pharmaceutical translations

Technical writing

ISO 13485 consultation

ISO 17025 consultation

HPLC troubleshooting and method optimization

 

If your request isn’t among those topics, but you’re interested in a cooperation with us nevertheless, please don’t hesitate to contact us (via phone, email to dr.thode@loesungsfabrik.de or by using our contact form). We’re sure we’re going to find a good solution together!