SpeQ Reports

"No job is finished until the paperwork is done"

SpeQ Reports is a company based in the eastern part of the Netherlands, founded by Drs. Ing. Michel Offringa in 2005. Pharmaceutical companies from all over the world can benefit from outsourcing the writing and review of several kinds of documents to SpeQ Reports:

• Research protocols and reports
• Scale-up protocols and reports
• (Process) validation protocols and reports
• Technology transfer documents
• Regulatory documents (module 3 using e-CTD and CTD guidelines, IMPD, IND, etc.)
• Analytical (data) documents
• Component specifications
• Material masters and inspection plans
• Waste management policies
• Quality System procedures (e.g. SOP's and Guidelines)

Within the above mentioned documents, reference standards provided by several international organizations are used, as well as your own internal criteria. For instance reference standards from the European Pharmacopeia (Ph. Eur.), the United States Pharmacopeia (USP) and the Food and Drug Administration (FDA) are used.

From present SpeQ Reports is the representative for Samarind RMS Regulatory Management Software for the Benelux region and Germany. The Samarind RMS software is a fit-for-purpose regulatory submissions software application that has been designed from the outset as a user-friendly and time-efficient toolset for pharmaceutical industry professionals who deal with regulatory affairs. With a Windows and even an On Demand version large as well as small (generic) pharmaceutical companies can create and view the complete electronic Common Technical Document (eCTD). For more information see the website of Samarind RMS.

Besides the above mentioned implementation/startup of the ISOtrain training management system can be performed.

The founder has had 3 years experience within the pharmaceutical industry on performing above mentioned projects. Also experience in performing validations and of international technology transfer is gained during this period. Therefore SpeQ Reports can also perform troubleshooting and (process validation) sampling on production processes of pharmaceutical dosage forms.

In addition to the Pharmaceutical Industry also the Chemical and Veterinairy Industry can benefit from SpeQ Reports. The founder has studied various aspects of chemistry and he followed this with 4 years experience within research companies, both analytical and organic.

SpeQ Reports is in close contact with several pharmaceutical companies and consultancy agencies for assistance and providing information and knowledge.