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.
GMP Manufacturing of oral and topical products in our GMP approved studies
Scantox manufactures small molecule IMPs for Phase I–II clinical trials in fully GMP‑certified facilities. Here we produce solid and liquid oral formulations as well as topical formulations for clinical testing.
Packaging options include blisters, HDPE bottles, glass containers, and customized clinical study labeling.
Our services include QC release, ICH aligned stability studies, controlled logistics, temperature‑monitored shipments, QP certification, and reconciliation/destruction after trials.
Technology transfer of manufacturing process to CMO for commercial manufacture
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.
Primary and secondary packaging and labelling of Investigational Medicinal Products
Primary packaging can be handled in various types of containers: HDPE bottles, blister packs, glass or plastic containers, tubes and custom solutions based on product type.
Secondary packaging and labeling according to clinical study requirements: Labeling of randomized and blinded studies, and multilingual labeling options in booklet form and adaptable to country specific regulations.
QA, QC and QP release of Investigational Medicinal Products
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
The Qualified Person (QP) certification process provides an extra layer of assurance, certifying that each IMP is safe for distribution in clinical trials. At Scantox we hold the QP role inhouse.
Generating the CMC part of the regulatory package e.g. IMPDs, INDs and other regulatory documents
We support the preparation of high‑quality Chemistry, Manufacturing and Controls (CMC) documentation that forms a critical part of your regulatory submissions. Our experts work closely with you to generate clear, compliant and scientifically robust CMC sections for IMPDs, INDs and related regulatory documents across the full development lifecycle.
By combining regulatory insight with hands‑on technical expertise, we ensure that your manufacturing processes, specifications and control strategies are presented in accordance with global regulatory expectations. This helps reduce review cycles, mitigate regulatory risk and keep your development timelines on track.
