Development services

Development services

We offer a broad range of development services to advance projects all the way from your initial idea to a Marketing Authorization.

Project Management / Documentation

Project Management / Documentation

According to our procedures for drug development we plan and manage the project with milestones, and support your needs for documentation, supply chain and quality assurance.

Regulatory support

Regulatory support

We advice your regulatory strategy, liaise with authorities and take care of quality agreements and supply contracts while compiling the dossier and ensuring a smooth application process.

Sourcing

Sourcing

We do sourcing of APIs, excipients and packaging materials, IMPs, nIMPs , in addition to auditing and approval of suppliers.

Sponsor for clinical development

Sponsor for clinical development

Based on your needs, we can support your clinical trial planning, IMPD and protocol writing; we take care of agreements and coordination of service providers an establish the product specification file.

Manufacturing

Manufacturing

We offer expertise and manufacturing services all the way from test batches, clinical trial batches and scale-up to commercial production / tech transfer, supported by all necessary qualification and validation.

CMC / Development lab

CMC / Development lab

If needed, we can support your formulation development and manufacturing process, with all necessary trouble shooting involved. Control of starting materials and finished products in included, as well as stability studies.

Clinical trial support

Clinical trial support

We can support most of your needs in clinical trial support: comparator sourcing, production, packaging, labeling, blinding, distribution, stability studies and QP services.

Key people

  • For general inquiries:

    Bibbi Paust

    Head of Quality Assurance
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  • Questions regarding Clinical Trial Services:

    Tone Lund Nordal

    Quality Assurance Associate / Qualified Person
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Contact

  • T: +47 21 60 87 00
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    Karihaugveien 22
    N-1086 Oslo
    Norway