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Contract Development

 

Contract Development of lipid-based active ingredients, extracts and formulations

Stabican offers flexible solutions that enable you to move your challenging fat-soluble molecules and/or extracts through each early development phase with efficiency and speed (e.g. Δ9-THC, psilocin, nicotine and vitamin A, D, E and K). Our early development solutions enable you to:

Overcome complex formulation challenges: bioavailability, solubility, stability, process
Navigate a complex regulatory environment (IND, filing, etc.)
Build success in early development to enable commercial success
Shorten timelines to get to market quicker

Our approach to successful product development

Stabican has access to all the necessary tools, process, technologies and services to facilitate
your product development to clinical trials and market launch:

Feasibility

We offer early-stage formulation development.
 

In a first experimental feasibility phase, we can support the following:

Experimental design
• Extract/isolate sourcing
• Preliminary Preclinical testing (dissolution, bioavailability, etc)
• Specification development
• Technology development and IP

 

Proof of Concept

In case of feasibility is proven successfully, we support the development of your Target Product Profile (TPP) with the following:
 

• Dosage form selection
Prototype batches for evaluation
Preclinical testing (dissolution, bioavailability, etc)
Supply chain
QA/QC plan
GMP transfer

Drug Product Development

When Proof of Concept is confirmed, the final stage of product development is supported by us with:
 

EU-GMP extract/isolate supply
GMP Clinical Test analysis
Process validation and optimization

 Full development of analytical methods
Scale-up from lab to pilot to commercial
Product Release
QA/QC support and regulatory support
GMP Manufacturing, up to pilot scale/Phase 3
   Tablets, Capsules, Granules, patches, liquids, inhalables

 

When preparing for market launch, we can negotiate Tech Transfer or Contract Manufacturing.

 
 

Interested?