Formulation Development
testings (analytical and efficacy based)
Re8 ensures you have the right partner for your formulation challenges who offers innovative technologies and helps you scale up processes and products.
Our specialized partner makes sure you get customized nanoparticles and microparticle (lipid/ polymeric) products developed as per current regulatory guidelines. Other related services like analytical, stability, technology transfer, ex-vivo, and preclinical studies are accessible under one umbrella
Routes of Administration
Our Expertise
Nanosuspension
Polymeric Nanoparticle
Sustained & Extended Rel Nanoparticles
Solid Lipid Nanoparticles
Nano & Micro Emulsions
Dendrimers
Tablets-capsules
Power-Granules
Gels
- In vitro testing
- Stability studies
- Packaging development
- Process optimization through QbD (ICH Q8)
- Process validation
- Manufacture of clinical batch
- Tech transfer – process
- Tech transfer–related analytical methods
- cGMP Clinical batch production
Before developing any formulation recipe, it is very important to understand the drug and excipients used for better physicochemical stability and in-vivo performance.
The labs are equipped to evaluate solubility, pH, compatibility and related properties to ensure the development of a stable, robust formulation for you.
Once we understand your formulation goals, we will study thoroughly the solubility and compatibility profiles of API for optimal formulation development. With insights like the tentative market and expected performance in humans, we are able to design an ideal drug carrier for you. Accordingly, we design innovative recipe compositions, currently, we are active in OSDF, parenteral and dermal formulation development areas.
Re8 is happy to support you in the development of a proof-of-concept formulation that is a perfect product fit for the preclinical, clinical and commercial phases.
Our team has a proven knowledge of effective product R & D and manufacturing process optimization. We optimize the prototype formulation for related stability and process development parameters to make your product commercially successful. Allow Re8 to be your first choice as a partner for formulation development and scale-up.
Stability studies are key, to ensure a product is ready to enter certain geographical areas. We optimize the prototype formulation for related stability parameters to make your product commercially successful. Our certified storage chambers and analytical methods make sure you get a stable product as per ICH guidelines.
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Intellectual Property
You remain sole owner of IP rights.