Socium Pharma Services
Your Strategic Partner for Seamless EU Pharmaceutical Solutions
At Socium Pharma Services, we pride ourselves on being your trusted partner in navigating the complex European pharmaceutical landscape. With over 60 years of combined experience, our team offers unparalleled expertise in EU batch certification, import services, and business development.
Whether you’re looking to bring your products to Europe or seeking guidance on business development and launch strategies, Socium Pharma Services is here to ensure a smooth, compliant, and timely market entry.
Socium Pharma Services
We offer a unique blend of deep regulatory knowledge, hands-on expertise, and a client-centered approach. With Marisca and Conny leading the way, Socium Pharma Services is your go-to partner. Let us help you unlock the full potential of the European market. At Socium Pharma Services, your success is our priority.
Unlock Europe with Socium Pharma Services:
Your Partner for Seamless Batch Certification, EU Import, and Business Development
Breaking into the European market can be complex, but with the right partner, it becomes an opportunity to thrive. Socium Pharma Services is more than just a service provider – we are your strategic ally, dedicated to ensuring smooth, compliant EU batch certification, EU import and business development. With our decades of expertise and in-depth knowledge of EU regulations, we’ll help your products land in the EU market timely and compliantely, so you can focus on what matters most: growing your business.
Why Choose Socium Pharma Services?
Comprehensive EU Compliant Batch Certification for Non-Sterile Medicinal Products
We manage batch review and certification in full compliance with EMA Directive 2001/83/EC and GMP Annex 16, ensuring your product meets European regulatory standards in all aspects.
Efficient EU Import Services
Our services cover all aspects of importing registered, non-sterile human medicinal products to the EU under Annex 21 of the GMP Guidelines—delivering peace of mind that your products will arrive in time and compliant to the applicable regulations.
End-to-End EU-Analytical testing support
Are you in need of EU QC analytical testing or support with analytical method transfers? We coordinate the entire process, providing expert guidance and ensuring smooth transitions to the EU’s QC lab network.
Strategic Business Development and In-Market Success
From advising on market opportunities to supporting logistic and technical aspects of product launches, we offer tailored business development services designed to optimize your success in Europe.
Local Expertise with Global Reach
Our Qualified Person (QP) has over 25 years of experience in certifying both generic and innovative medicines. As your local EU contact, we ensure swift, compliant batch certification that aligns with your timelines.
Trusted Expertise, Proven Results
Over the last 25 years, our Managing Director has built a solid track record in Business Development and EU imports. We understand the complexities of the European pharmaceutical landscape and stay up to date with the latest regulatory requirements, enabling us to expedite your product’s entry into the EU market without unnecessary hurdles.
Efficient and Effective
With short communication lines and a highly responsive team, we stay focused on getting the job done efficiently and effectively. We are with you every step of the way-keeping your goals front and center.
A Partnership for Success
At Socium Pharma Services, we view your success as our own. We are committed to providing hands-on support, strategic insights, and a streamlined approach that ensures your product launches on time and in full compliance with EU standards.
Our Services Include:
- Financial and Physical EU Import Solutions
- Batch Document Review (e.g. Batch Manufacturing & Packaging Records, transport conditions)
- EU Batch Certification for Marketing in the EEA
- Coordination of EU QC Testing
- Retention and Reference Sample Storage
- Issuing QP Declarations for Registered Products and Product under Application
- Auditing Manufacturers & Supply Chain against EU-GMP & GDP requirements
- Managing Transport Deviations, Temperature Excursions, and CAPAs
- Business Development Counselling
- In-Time Market Launch Strategies
Contact us today…
…to explore how Socium Pharma Services can be your gateway to successful EU market entry. Let’s partner for timely, compliant and seamless entry of your products into Europe.
Socium Pharma Services B.V.
The Netherlands | E: services@sociumpharma.nl | Chamber of Commerce 91851750