CURRENT HOT TOPICS RELATED TO UPDATED FDA AND EMA GUIDELINES (LIFECYCLE APPROACH):
- DATA INTEGRITY
- PROCESS & CLEANING VALIDATION
- CONTINUED / CONTINUOUS PROCESS VERIFICATION
SpeQ Reports is based in the eastern part of the Netherlands, founded by Drs. Ing. Michel Offringa in 2005. SpeQ Reports has over 10 years of experience as a contractor within the pharmaceutical industry.
SpeQ Reports has extensive GMP experience within the pharmaceutical industry related to writing GMP documentation, including template creation and spreadsheet creation and validation.
Reference standards provided by several international organizations are used, for instance EMEA, FDA, Ph. Eur., USP and ICH.
Pharmaceutical companies can benefit from outsourcing projects related to all kinds of Good Manufacturing Practices (GMP) documentation.
In addition to the pharmaceutical industry also the Food, Veterinary and Chemical industry can benefit from SpeQ Reports.
The founder has studied various aspects of chemistry and has 5 years of experience within chemical research companies (analytical and organic chemistry related).
