News

Q4/2017 Guinness Book of Records

This quarter we were facing significant changes within our team as both Susil Chotoe and Ivan Utama decided to leave our company in pursuit of new career options within pharmaceutical companies. We very much regret such changes as these represent a loss of experience and client-specific knowledge. However, we were

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Q3/2017 Dimension, what dimension?

To mark our 30th anniversary in April this year, we evaluated our various global clients for their Hofstede dimensions. Consult the respective page on our website to find out how various countries worldwide score on this socio-cultural measuring scale with respect to their power distance, indulgence, uncertainty, individualism, femininity and long/short-term

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Q2/2017 The EMA in Amsterdam?

Twenty something European cities are currently chasing the EMA to become the new host of this respectable institute surveying the medicinal products in the EU after the Brexit. Amongst these you’ll find our capital Amsterdam which recently submitted its bid-book to the EU in Brussels. A new office building is

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Q1/2017 At last: the EU – FDA MRA

By far the most exciting news of this quarter has been about the EU and the USA regarding their mutual recognition agreement (MRA). This MRA concerns the mutual acceptation of health care inspectorate certification of pharmaceutical manufacturing companies. As of November 2017 this brings to an end the time consuming

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Q4/2016 The Brexit Garden

The year 2017 will mark our 30st anniversary and throughout this lifetime our service portfolio has extended wildly in all directions along with the growth of the regulatory framework in the European Union. Pricing & Reimbursement, Pharmacovigilance and Promotional Compliance initially were rather minor and straightforward but now extensive procedures

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Q3/2016 Our week with the FDA

For the first time in our history we supported one of our clients with the preparation for a GMP audit to be conducted by the FDA. Such an audit is something completely different as compared to similar audits by the Dutch Inspectorate. While the latter usually needs 1- 2 days

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Q2/2016 Big data or big deal?

This quarter marks the breakthrough of data-integrity as a new important element of GMP-systems worldwide. While the MHRA already issued its Guidance for Industry in March 2015, in April 2016 the FDA issued a similar guideline. So we will have to prepare ourselves for this theme to arrive on the

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Q1/2016 Our license hattrick

With the receipt of our pharmaceutical wholesale license, this quarter marks the finalization of the logistic service concept of our company. With the presence of an import license, narcotic license and our newly obtained wholesale license we will be able to support any client who needs logistic support next to

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