Novitan | Knowledge hub

What regulatory certifications does Novitan maintain?

Novitan operates under EU GDP (1216 H), GMP (1216 IMP) certification, and additional licenses for storage of controlled substances.
We maintain compliance with EMA guidelines and FDA CFR211 regulations.

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What are your storage capabilities?

Our Belgian facility features over 2,000 square meters of validated controlled-temperature storage space across ambient (15-25°C), refrigerated (2-8°C), and frozen (-25°C to -15°C) conditions.

All storage areas include continuous temperature monitoring, backup power systems, and 24/7 alarm monitoring. We can accommodate both small-scale early-phase studies and large Phase III trials, with flexible storage agreements and rapid scaling capabilities as your study progresses.

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Can you handle global clinical trial logistics?

Absolutely. Our European base provides strategic access to all EU countries, while our global transport partnerships enable worldwide distribution.

We manage multi-temperature shipments, customs documentation, import/export licensing, and country-specific regulatory requirements. Our experienced logistics team coordinates with local and global distributors, ensuring your clinical supplies arrive on time and in perfect condition.

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Can Novitan act as Importer of Record

Yes. Novitan can act as the Importer of Record (IoR) for clinical trial supplies entering the EU.

As your designated IOR, we assume full responsibility for:

Managing import documentation, permits, and licenses
Handling customs clearance, duties, and VAT payments
Ensuring compliance with EU regulations
Maintaining GDP standards for pharmaceutical imports

By serving as IoR, Novitan streamlines the import process, prevents regulatory delays, and ensures compliant, efficient delivery of clinical materials across the EU.

What makes Novitan different from the larger CMOs?

Novitan specializes in medicines access and clinical trial services. With a core dedicated team, our entire operational structure is designed around timeline flexibility.

Our senior leadership maintains direct involvement in project decisions, enabling instant responses to change requests and urgent scheduling needs. We can rapidly pivot to offering expedited services and often accommodate requests for timeline enhancement that might require more complex approval processes at larger, multi-divisional companies.

What is a comparator drug

A comparator drug (also known as a control) is the reference product used in a clinical trial. The group receiving the comparator is called the control group.

Comparators can be: an approved, commercially available medicine, representing the current standard of care, or a placebo.

Comparators play a crucial role in generating meaningful and reliable clinical data.

At Novitan, we specialize in sourcing commercially licensed medicines used as comparators from global markets and providing blinding and packaging services to maintain trial integrity and regulatory compliance.

How do you ensure product authenticity?

We source exclusively from licensed pharmaceutical distributors and manufacturers, maintaining complete Chain of Custody documentation from origin to delivery.

Our quality and procurement team verifies supplier licenses, conducts physical inspections, and maintains detailed pedigree records. Additionally, we provide EU FMD compliance services and implement serialization tracking for enhanced security throughout the supply chain.

How should we handle sponsor address changes on existing clinical trial labels?

It is important to first obtain written confirmation from the regulatory authority that existing labeled inventory can be used as-is under the condition that an accurate label will be created later. During this time we can design a new label for future batches.

Alternatively, Novitan can isolate current stock, apply an updated address label and coordinate shipping reworked supplies back to sites—ensuring continuous patient dosing without delays or product waste.

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Frequently asked questions

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