Manufacturing
NUVISAN offers formulation development and manufacturing services for a quick entry into Phase I, such as:
- Oral powders for reconstitution
- Automatic capsule filling:
- Sizes: 4, 3, 2, 1, 0, 00, C, B, AA, AAA
- 100% weight control
- Capacity up to 75.000 conventional capsules and 15.000 over-encapsulations per shift (further options with semi-automatic equipment on request)
- Tablets to be used as matching placebo
- Semi-solid formulations (creams, gels, ointments), including formulation development
- Oral liquid formulations (solutions, syrups, suspensions, elixirs and concentrate)
No matter if you favour the exploratory formulation approach for the simplest possible formulation or a commercial formulation approach, we support your development needs.
Our scientists offer development of semi-solid topical and oral liquid formulations, including a reliable strategy to reduce risks on scaling-up and strong support considering the industrial transfer for future commercial stage.
In-house GMP-compliant analytical services, including method development and method validation, round out early-stage manufacturing needs. GMP-certified testing can be offered for both small and large molecules.
Packaging & Labeling
Primary Packaging/Immediate Packaging
Our primary packaging services include filling your products into glass or HDPE bottles (optional: induction sealing or desiccant caps), as well as glass jars, bottles, and aluminium or plastic tubes for gels, ointments, creams, or lotions.
NUVISAN also offers blister packaging tailored to your products and clinical design, producing mono-blisters or mixed blisters. Available materials are:
- Thermoforming: PVC/Alu, PVC/PVDC
- Triplex, COC (Amparis®), Aclar®
- Cold Forming: Alu/Alu
Due to an automatic visual control system and inline printing on blisters, NUVISAN ensures your products are professionally packaged. Furthermore, we can fulfil special packaging requirements such as child-resistant and senior-friendly packaging solutions, or smart packaging.
To complete your needs for clinical trials, we offer a wide range of stability testing in the selected packaging container. With chambers having a total of more than 320 m3 and temperatures from -70°C to +60°C (zone I to zone IV), NUVISAN covers all possible requirements. We also offer cycling and compatibility studies, as well as photostability, in-use stability, transportation stability, and stress testing in addition to sample storage.
Blinding
NUVISAN’s experts provide reliable solutions for blinding your investigational medicinal products, e.g.:
- Different types of solid dosage forms, from single tablets to multiple mixed components, by over-encapsulation
- Pre-filled syringes
- Blinding inhalers
- Tubes
NUVISAN offers randomization services by internal biometricians. Based on the protocol, a randomization list is created by using a qualified and validated software.
The printing of emergency/code break envelopes is also performed by NUVISAN’s Clinical Trial Supplies unit.
Secondary Packaging/Outer Packaging & Labelling
To address your specific clinical packaging needs, we offer packaging into blister cards, wallets, and customized patient kits, combining different products needed for the application and/or take-home medication.
In case of temperature sensitive products, NUVISAN performs the secondary packaging and labelling in one of our walk-in refrigerators or walk-in freezers. For temperature sensitive products, labelling can be done at 2-8°C, -20°C, and below -60 °C (on dry ice), in a temperature-controlled GMP environment.
For the labelling of investigational medicinal products, NUVISAN offers a portfolio of various label formats (e.g., single labels, flag labels, wrap-around labels, and booklet labels), which are selected based on the individual needs of the study. Barcodes, QR codes, graphics, fonts, and colors can be applied to your labels according to your study specific needs.
QP Release
All GMP activities are done under the supervision of EU Qualified Persons (QPs) located at our two GMP facilities. Our six full-time Qualified Persons are well-experienced to release various types of finished products (oral, topical, sterile, and biological drugs as well as vaccines and blood products) according to European GMP standards.
Moreover, no matter whether you need QP services for investigational, compassionate use/expanded access or commercial products, we can meet your requirements.
For importing medicinal products into Europe, the qualification of third country manufacturing and testing sites through an audit and the issuance of the QP declaration and application for the import permit is also a service we can offer. Our professional QPs are familiar with global supply chain evaluations.
Logistics & Depot Solutions
NUVISAN’s overall GMP area consists of 2 850 m2 access controlled, qualified, and temperature monitored rooms. Qualified storage capacities for ambient, 2-8°C, -20°C, and -80°C are available.
A secured storage for controlled drugs as well as the appropriate storage of reference and retention samples is available.
Expertise in proper demand planning and global distribution management allows us to minimize both product quantities and timelines. Distribution manuals are created to outline all necessary documentation, IRT interaction, courier, and depot information.
Our broad network of qualified couriers and depots ensures that your global supply chain is efficiently organized, and your product will arrive in due time at clinical site.
Drug Return, Accountability & Destruction
At the end of the clinical trial, we organize your drug returns from the clinical sites, perform the drug accountability according to your specific level of detail (e.g., dosage form count/kit count/usage) and provide you with the appropriate reports. After receiving your approval, we organize the qualified destruction and the associated destruction verification reports are issued.
As a matter of course, we offer those services globally.
Supporting Solutions
- Regulatory support, e.g., CMC writing or review
- Translation services with regards to label texts and instructions for use
- Realizing your compassionate use/ expanded access programs, esp.:
regulatory support, labelling, storage, and worldwide distribution services
- A well-established global network of qualified partners allows us to offer the best solutions for comparator sourcing, considering shelf-life, pricing, and the required batch size
