Frequently Asked Questions
If you don't see your question here, reach out—our team will respond quickly.
Do you operate under cGMP and ISO 9001:2015?
Yes. Our facilities are FDA-registered, cGMP-compliant, and ISO 9001:2015 certified. We maintain electronic batch records, data integrity controls, and full traceability.
What project information do you need to start?
Target product profile, intended market (pharma, OTC, nutrition, veterinary), desired dosage form, API or active characteristics, expected volumes, and timeline. A CDA can be put in place prior to sharing sensitive details.
Can you support both development and commercial supply?
Yes. We provide feasibility and pilot work, then scale through validation and commercial supply. Tech transfer packages are available if you plan to manufacture at your own site later.
How do you approach taste masking and sensory improvements?
Our MicroMask® platform combines microencapsulation, coating selection, and sensory testing to eliminate bitterness and odor while meeting dissolution targets.
What analytical services are available?
Method development and validation, routine release testing, stability programs, and characterization such as PSD, moisture, assay, dissolution, and hardness/friability for solid dose.
Do you provide samples or data sheets?
Yes. We can share specifications, CoAs, and representative samples for evaluation once we align on the intended application.
Talk with Our Technical Team
We can address project-specific questions, regulatory needs, and supply considerations.
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