Zelmic · IMP Manufacturing & Clinical Supply
Clear answers to the questions sponsors ask most about supplying Investigational Medicinal Products (IMPs) for First-in-Human and early-phase trials: GMP manufacturing, QP release, the IMPD, dosage forms, batch sizes, import, and the integrated path from formulation to clinical supply.
An Investigational Medicinal Product (IMP) is a pharmaceutical form of an active substance or placebo being tested, or used as a reference, in a clinical trial. This includes products not yet authorised, authorised products used in a new way or for an unapproved indication, and the comparators and placebos used in the study.
IMPs must be manufactured to Good Manufacturing Practice (GMP) standards appropriate for clinical trial use.
A First-in-Human (FIH) study is the first clinical trial in which an investigational drug is given to human participants, usually after preclinical testing. FIH trials are typically Phase I studies that evaluate safety, tolerability and pharmacokinetics, often starting at low doses with careful escalation.
They require a well-characterised IMP manufactured and released under GMP.
GMP manufacturing of IMPs for FIH involves producing the clinical trial material, including the drug product and any placebo or comparator, under controlled, documented and quality-assured conditions suitable for human use.
This covers manufacture of the dosage form, in-process and quality control testing, packaging and labelling for the trial, and certification by a Qualified Person before the batch can be released for use in the study.
In the EU, every batch of IMP must be certified by a Qualified Person (QP) before it can be released for use in a clinical trial. The QP confirms that the batch has been manufactured and tested in accordance with GMP, the clinical trial authorisation and the product specification file.
QP certification is a legal requirement and the final quality gate before the IMP reaches trial sites.
An Investigational Medicinal Product Dossier (IMPD) is the documentation submitted to regulators as part of a clinical trial application, describing the quality (manufacturing and control) as well as the non-clinical and clinical data of the IMP.
The quality (CMC) section must be consistent with how the IMP is actually manufactured and controlled, so manufacturing, analytical and regulatory work need to be aligned from early on.
Zelmic manufactures non-sterile IMPs for early clinical studies, including topical dosage forms such as creams, gels and ointments, and oral dosage forms suitable for early-phase trials. Flexible batch sizes are used to match the smaller quantities typically needed for First-in-Human and Phase I programmes.
First-in-Human and early-phase trials usually need relatively small quantities of IMP, so manufacturing is set up for flexible, small batch sizes rather than commercial-scale production. This keeps material use and cost efficient while still meeting full GMP and QP-release requirements.
Clinical trial supply includes primary and secondary packaging, trial-specific labelling that meets regulatory requirements (including blinding where needed), and the logistics of getting QP-released IMP to trial sites. Labelling and supply must align with the approved protocol and clinical trial authorisation.
Yes. A manufacturer or importer holding the appropriate authorisation can import active pharmaceutical ingredients (APIs) and finished IMPs for use in EU clinical trials, with a Qualified Person certifying imported IMP batches before release. This allows sponsors to source material internationally while meeting EU GMP and release requirements.
IMP manufacturing in the EU falls under the Clinical Trials Regulation (Regulation (EU) No 536/2014) and the associated GMP requirements for investigational medicinal products. Manufacturers and importers of IMPs must hold a Manufacturing and Import Authorisation for IMPs and release each batch through a Qualified Person.
Specific requirements depend on the product and trial and should be confirmed against current regulatory guidance.
An integrated provider connects formulation development, analytical and CMC work, GMP manufacturing and QP release, regulatory support including IMPD preparation, and clinical conduct within one pathway.
Zelmic provides formulation development, analytical chemistry and EU GMP manufacturing of IMPs, and — as part of the CTR Group — works alongside partners covering clinical trial management and First-in-Human conduct, regulatory strategy and quality assurance, reducing handovers from early development to clinical supply.
Talk to Zelmic about manufacturing, QP release and clinical supply of your IMP — and the integrated path from formulation to the clinic.