blog — apislabor.org

The Critical Role of Technical Due Diligence in Pharmaceutical Mergers, with Expert Support from APIS Labor

In pharmaceutical mergers and acquisitions, technical due diligence is essential to identify risks and ensure regulatory compliance, IP protection, and operational efficiency. Pharma companies often rely on consultants like apis labor to conduct thorough assessments in areas such as regulatory compliance, intellectual property (IP), R&D pipelines, manufacturing, and technology infrastructure.

apis labor consultants specialize in evaluating key factors that impact the success of M&A deals, such as quality systems, patent validity, product portfolio strength, and talent retention. Their expertise helps acquiring companies make informed decisions, mitigate risks, and maximize value, ensuring a smooth integration and long-term success.

By leveraging apis labor technical due diligence services, pharma companies can confidently navigate the complexities of mergers and unlock new growth opportunities.

GMP ConsultingThomas Pfeifer11 September 2024apis labor GmbHGMP Labor

EU Batch Release and GMP Requirements for Importation of Pharmaceuticals

The European Union (EU) has implemented stringent regulations and quality standards for the importation of pharmaceutical products to ensure patient safety and product efficacy. Two critical aspects of this regulatory framework are the EU Batch Release and Good Manufacturing Practice (GMP) requirements. In this blog post, we will explore the significance of EU Batch Release and GMP requirements for the importation of pharmaceuticals into the EU market.

The implementation of new software systems in GMP regulated areas

Computerized System Validation is crucial in the pharmaceutical sector to ensure the operational efficiency of electronic systems. It is a continuous process that begins with identifying the functional requirements and involves comprehensive testing to confirm that the system remains reliable and compliant with regulatory requirements.

GMP Consulting, iCONNECTThomas Pfeifer29 May 2023CSV, Validation, GMP

augmented reality in GMP laboratories

Our LIMS is integrated in all our processes and basically acts as an additional member of our team, automating workflows and tracking all the important sample information, data, workflows, and QA/QC results. Furthermore, we are able to log in not only from our computers and labtops but also using all different kind of devices, for example iPads, Surface etc. The Microsoft HoloLens2 is the next device which we are connecting to the LIMS System in order to document processes handsfree

iCONNECTThomas Pfeifer27 February 2021AR, GMP LAB, GMP Labor

Efficiency within Quality Control, UHPLC conquering PHARMA

UHPLC technology provides high analysis speed, better chromatographic resolution, performs more sensitive analysis, consumes less time, reduces solvent consumption. Although these facts are proven, the implementation if this technology shows only slow progress within the quality control of pharmaceutical.

We have developed a strategy how methods can be transformed and all the benefits including cost savings can be seen in short time.

We provide Business case, Regulatory Strategy and Registration Documents, Method Validation Documents according to ICH, Testing Procedure and Project Plan.

new release of validation guide for computerised systems

ConsultingThomas Pfeifer18 April 2018apis labor GmbHLIMS, digitalization, paperless lab, GMP Labor, Labor der Zukunft