Services
Our pharmaceutical consulting services are tailored to your specific needs. Whether you need support during the innovative drug development process, need advice on expanding into new markets, or need a helping hand in quality assurance, you can contact us at any time to find out what we can do for you.
Ad Hoc Consultancy
We offer a comprehensive range of pharmaceutical consulting services in quality and regulatory affairs on an ad-hoc basis. If you are in need of incidental or a one-off service, we are available for remote and on-site support.
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We help you with your specific needs in the fields of:
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EU pharmaceutical legislation
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Quality management
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Drug market access
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Regulatory due diligence
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Medical and technical translations
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Promotional compliance
GxP Compliance
GxP comprises all good practice quality guidelines and regulations (e.g. GCP, GDP, GMP). We understand the complexity of the pharmaceutical legislation and are able to guide you in the right direction.
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Our GxP compliance services include:
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Quality management system development and optimization
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Quality investigations
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Risk and gap analyses
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Audit support
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Quality oversight and release
Dossier Development
We provide regulatory documentation and procedural support during any stage of your drug development process. We help companies, both large and small, and across a wide range of products, including new chemical entities and (specialty) generics, to move towards their dossier requirements.
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We support you with:
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Regulatory submission strategy advice
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Preparation of documentation of marketing authorization applications (modules 1-3)
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Liaison with national competent regulatory authorities
