Ensuring that your Investigational Medicinal Product is manufactured and packaged with outmost precision and attention to detail is crucial to the success of clinical trials. Scantox offers GMP manufacturing and packaging services, specifically for small molecules, ensuring regulatory compliance at every step of the process.
Comprehensive Services for Early-Stage Clinical Trials
We manage all phases of your product development lifecycle and associated supply chain to meet your project’s specific needs.
GMP Manufacturing Capabilities
At Scantox, our GMP-approved facilities and highly trained team specialize in the manufacturing of oral, topical, and solutions used in inhalation products for small-molecule APIs in early-stage clinical trials (Phase I and II). Operating with the highest precision standards, we produce over 100 GMP lots annually, complying with European and US standards. We quickly adapt to your project’s unique demands, whether you’re facing tight deadlines or urgent requests.
Once the GMP product has been manufactured, we ensure that your product is prepared for clinical trials with meticulous attention to packaging, which plays a critical role in maintaining product integrity and compliance. Our solutions include:
Primary Packaging
- Blister packs
- HDPE bottles
- Glass containers
- Custom solutions based on product type
Secondary Packaging
- Labeling according to clinical study requirements
- Multilingual labeling options or adaptability to country-specific regulations
Quality Control, and Stability Testing
Before the clinical trial phase, every product undergoes rigorous ICH-compliant testing to ensure safety, potency, and stability. Quality Control (QC) release testing is designed to verify that each batch meets stringent regulatory standards, ensuring your Investigational Medicinal Product (IMP) is ready for clinical use.
Stability studies provide critical insights into shelf life, ensuring your product remains consistent and reliable throughout the study.
We perform stability testing at all ICH conditions and regulatory guidelines to establish shelf life of product
Qualified Person Certification
The qualified Person (QP) certification process provides an extra layer of assurance, certifying that each IMP is safe for distribution in clinical trials
Distribution and Return Services
Once your product is ready for clinical use, we manage the distribution of Investigational Medical Products (IMPs) to clinical sites under controlled conditions, ensuring product integrity throughout the supply chain. Collaborating with approved logistics partners, we offer temperature-controlled storage and shipment, with data loggers documenting environmental conditions to maintain compliance and quality.
After your trial is complete, we will manage the safe return of IMPs and ensure the secure reconciliation and destruction of any unused or expired materials including preparing a destruction certificate, all while adhering to stringent regulatory standards.
Scale-Up and Technology Transfer
As your project progresses, we assist with scaling up the manufacturing process or transferring technology to Contract Development Manufacturing Organizations (CDMOs) for commercial production. Our expertise ensures a seamless transition, maintaining product consistency and quality.
Quality Assurance and Compliance
Quality is the cornerstone of our operations. The Danish Health Authorities fully certified us for GMP manufacturing, primary and secondary packaging, QC testing, and QP certification of IMPs, and we strictly adhere to European Medicines Agency (EMA) guidelines.
GMP Certificates
Download our certificates:
Certificate number DK IMP 10000944
Our quality management system includes documented Standard Operating Procedures (SOPs) for every product and process, detailing manufacturing methods and components. All raw materials, excipients, and packaging components are sourced from qualified suppliers and thoroughly tested before use. Each product is manufactured according to these detailed procedures and, upon completion, is analyzed and approved by quality control before release.
Partnering with Scantox
We are committed to accelerating your drug development process with high-quality manufacturing and packaging solutions. As a small, agile organization, we offer the flexibility, expertise, and competitive pricing that make us an ideal choice for small and medium-sized companies.
Learn how we can guide you through each step of your drug development journey, from initial manufacturing to final product release.