Our experienced and proven team of scientists, engineers and regulatory professionals, will deliver your molecule or biologic in the optimal drug formulation while ensuring the highest-quality standards in drug development and drug delivery systems utilizing QbD principles for oral and parenteral dose forms.
ContactPii enables biotech and pharmaceutical companies to dramatically accelerate timelines with our proven capabilities in aseptic filling, terminal sterilization and lyophilization of biologic NCE, small molecule, potent up (HPAPI) to SafeBridge® Category 4 and cytotoxic drugs into vials, syringes and cartridges. Our focus is on accelerating decision-making at every step of the drug development process utilizing QbD to meet your project milestones, while also providing rapid access to manufacturing slots and quick release of drug product for clinical trial or commercial supply. All parenteral products are processed and tested in strict accordance with cGMP requirements. Our services include:
Our range of oral dose delivery options gives your drug excellent solubility and stability, delivering the right dosage at the right time in the patient’s body. This is where Pii’s proven and experienced formulation scientists will be invaluable in the early stages of development to ensure meeting the target product profile (TPP) by providing a forward-thinking approach to anticipate and eliminate potential future challenges.