Clinical Trial Supplies

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With more than 40 years’ experience as a Clinical Trial Supplies service provider, NUVISAN offers the full range of services in the area of clinical drug supply to include:

  • Regulatory consultancy, CMC support
  • Non-sterile manufacturing services, including matching placebos
  • Packaging and labelling services, including cold chain packaging
  • Creation of randomization lists
  • Analytical testing, including stability testing
  • Just-in-time labelling and distribution
  • QP services
  • Comparator sourcing
  • Storage and worldwide distribution for a variety of clinical materials
  • Return, reconciliation, and destruction services
  • Direct-to-patient shipments
  • Compassionate use and expanded access services
  • Controlled drug handling

The Clinical Trial Supplies department supports your needs by supplying medicinal products for use in Phase I-IV clinical trials as well as compassionate use /expanded access programs.

NUVISAN also holds several licenses to serve the industry and to meet regulatory requirements. A Manufacturing and Import Authorization (MIA) for human and veterinary investigational medicinal products is currently in place as are licenses for commercial products’ batch release and analytical testing as well as controlled drug handling and storage.

NUVISAN provides GMP services out of our facilities in Germany and France. The sites are both, complementary with regards to special technologies, as well as mutual back-ups in core technologies. This provides utmost flexibility and reactivity in the services offered.

MANUFACTURING & FORMULATION SERVICES

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

No matter if you favor the exploratory formulation approach for the simplest possible formulation or a commercial formulation approach, we support your development needs.

Scientists at our NUVISAN France location offer development of semi-solid topical 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.

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 aluminum 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 fulfill 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.

STORAGE & DISTRIBUTION SERVICES

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.

ADDITIONAL SERVICES: CONSULTANCY, SOURCING & CO.

  • 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
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Our Services & Solutions along
the Drug Development Value Chain

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Discovery

PRECLINICAL

Clinical Phase I

Clinical Phase II

Overall Services

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management