Sharing the Experience – our mission and our promise.
Our highly professional and qualified team will be happy to support you with your projects. DREHM Pharma offers consulting services for pharmaceutical firms and food companies. This includes not only development and production, production logistics, quality management, regulatory affairs and medical writing, but also pharmacovigilance and scientific marketing.
Take the opportunity to learn more about our services and our team by browsing through our website.
Our current Hot Topics
Audits – in all areas
Audits are an essential element of the compliance of every company.
Whether you have an authority inspection coming up or would like to evaluate internal processes – DREHM Pharma is your reliable partner for the planning and execution of audits and internal process inspections.
DREHM Pharma is happy to assist with audits for GMP, GDP, GVP, GSP, IT as well as data compliance, interfaces, project management, biologicals, environmental management and occupational safety.
Regulatory Affairs – on demand and full support
You need strategic advice for your drug approvals?
Your resources are scarce and you need full support for your medicines?
Your company needs support with a specific projects or only specific services on demand?
DREHM Pharma offers years of experience and comprehensive expertise in all regulatory issues.
We are also happy to take over artwork testing, the function of information officer, applications for the Austrian „Hauptverband der Sozialversicherungsträger“ as well as entire agency communication – so you can once again concentrate on your core business!
We make your Patient Leaflets accessible!
Did you know that in Austria, all Marketing Authorisation Holders must provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020?
This can be a challenge for everyone, as most of us struggle with capacities.
DREHM Pharma can help you with converting your Package Leaflets to the accessible standards and can train your staff.
Serialization – Falsified Medicines Directive
The implementation of the EU directive 2011/62/EU starts on 09 February 2019. This directive requires a clear labelling of each pharmaceutical package to prevent counterfeiting.
Your company has certainly already taken all precautions in production and labelling to meet the deadline.
Nevertheless, problems or unmanageable challenges can still arise in your company, from production through to the representation in the quality management system.
DREHM Pharma is always there for you – contact us.
Medical Devices
The new EU Regulation 745/2017 on medical devices, which comes into force on 26 May 2020, poses a new challenge.
How do you draw the right line? What documentation is required?
DREHM Pharma helps with these questions, evaluates your technical documentation, supports you in regulatory matters, advises you on labelling and advertising materials and is also there for you in vigilance matters.
If you want to know more about us, contact us us or stop by for a coffee. Our door is always open for you.