Our IMP management suite is able to handle compounding of various dosage forms:
- Sterile products for parenteral administration including intravenous (iv), intramuscular (im) and subcutaneous (sc)
- Non-sterile products such as: capsules, solutions, suspensions and topicals
- Solutions for inhalation/nebulisation
Additionally, our IMP services can include:
- Primary and secondary packaging
- Double-blind randomisation and code break envelope production
- Annex 13 compliant IMP label design
- Storage (ambient, refrigerated, -20°C, -70°C)
- GDP-compliant IMP distribution to external sites
- Reconciliation, return and destruction of IMP
- Procurement of comparator products and NIMPs
Regulatory expertise and compliance
Our IMP management suite is GCP-compliant for efficient handovers of products from the IMP suite pharmacy to our in-house Clinical Pharmacology Unit (CPU).
We also adhere to full Good Distribution Practice (GDP) for external distribution of your IMP. This ensures the product is fully safe, compliant and ready for your study.
We can aid with compliance submissions and facilitate rapid contact with the appropriate Regulatory Health Authorities, Ethics Committees and Notified Bodies during the development and maintenance phase of your clinical trials.
Our Qualified Persons (QPs) can aid with declarations, the certification of IMP batches, and the compliant importation of IMPs into the UK.