Phase 2 & 3 Clinical Manufacturing Services
We are fully equipped and accredited to manufacture a wide range of products for Phase 2 and small-scale Phase 3 trials. We provide this service to pharmaceutical and biopharmaceutical clients throughout the world.
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Details
Quay Pharma has the expertise and the capabilities to manage complex formulations under comprehensive regulatory and rigorous quality assurance procedures.
We have in-house GMP capabilities to handle liquid and solid dosage forms, including cytotoxic drugs, hormones, and potent drugs. We also manufacture and supply controlled drug products, and we are one of the limited number of manufacturers in the UK licensed to produce specials.
Using state-of-the-art facilities and supported by our in-house analytics specialists, our experts ensure that products are seamlessly scaled-up and transferred to clinical quantity manufacturing.
We provide comprehensive support to clients through the often complex process of licensing their product or moving on to Phase III or commercial contract manufacture by writing technical transfer packages and offering practical advice whenever required.
Our Production Capabilities Include:
- Direct compression tablets.
- Wet granulated tablets.
- Coating using immediate release and modified release polymers.
- Spray drying technologies.
- API layering on to nonpareils.
- Extrusion, spheronisation and pellet coating.
- Powder, granule and pellet filled capsules.
- Liquid and semi-solid fill into capsules.
- Thermally reversible gels.
- Ointments and creams.
- Aqueous and non-aqueous based gels.
- Aqueous and non aqueous based liquids and syrups for adults and children.
- Wet and dry suspensions.
- Nasal sprays.
- Products for terminal sterilisation, including liquids and gels.
- Comparator-blinding services, including encapsulation and coating.
- Placebo development for use in blinded studies.
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