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Injectables are leading the way in drug delivery innovation, and we’re here to help you launch your product efficiently. Whether you need prefilled syringes or extended-release formulations, our dossier-oriented approach and extensive regulatory knowledge support successful filings for everything from small molecules to biosimilars. Partner with us to shape the future of advanced therapies in complex generics.
Inhalation drug delivery can be complex, but our skilled team is ready to tackle the challenge. We support a wide range of techniques, including aerosols, vapours, gases from nebulizers and atomizers, dry powder inhalers, and metered-dose inhalers (MDIs). Our specialized infrastructure, including negative-pressure chambers, ensures safe and controlled environments for your complex generic studies. We also invest in thorough training for our volunteers to standardize dosing procedures, guaranteeing reliable results tailored to the unique needs of pulmonary administration.
Looking for precision in your metabolic research? Our team has extensive experience with insulin studies, including Glargine, Wosulin, and Aspart. Our GCP-trained staff conducts clamp studies ranging from 8 to 36 hours with precision. Equipped with dedicated facilities and advanced glucose analyzers, we ensure safety and data integrity throughout the process. From data evaluation to emergency handling, we’re committed to supporting you at every step.
Conducting studies with suppositories requires expertise and attention to detail. Trust us to handle your complex generic suppository trials with care and precision. We have a database of experienced volunteers and trained professionals to ensure precise dosing in temperature- and humidity-controlled environments. With our commitment to quality execution and data integrity, you can trust us to help your trial succeed.
We excel in conducting transdermal patch trials that meet both regulatory and clinical requirements. Our services include adhesion studies, pharmacokinetic evaluations, and assessments of skin irritation under real-world conditions. Our team has experience with dermatological treatments for conditions like psoriasis and acne vulgaris, handling products such as Clindamycin and Adapalene. With our expertise, your complex generic studies are in capable hands.
Need to fast-track your drug development? The 505(b)(2) pathway is a powerful option for accelerating drug approvals, and we have the expertise to guide you through it. We offer comprehensive support for formulations like orally disintegrating tablets, sublingual sprays, and ophthalmic solutions. Our services include clinical studies such as bioavailability/bioequivalence (BA/BE), pharmacokinetics/pharmacodynamics (PK/PD), drug interaction studies, as well as robust non-clinical assessments. We're dedicated to accelerating your success while ensuring quality and compliance.
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Guidance
Authorized generics are approved brand-name drugs that are marketed without the brand name on their label.
A branded generic is a generic drug that has gone through the ANDA process and is assigned a name other than the chemical name.
Complex generics are generics that could have a complex active ingredient, complex formulation, complex route of delivery, or complex drug-device combinations.
Specialty generics are the generic versions of specialty pharmaceutical products. Specialty generics include biopharmaceuticals, blood-derived products, and complex molecules.
A super generic drug is an improved version of an original drug that has lost product patent protection.
Once that patent expires, other companies can sell the drug under its generic name. The unbranded drug has to be identical in its active ingredient, strength, safety, and dosing.
Injectables
Studies via 505b2 Pathway
Inhalation Studies
Transdermal Patches
Glucose Clamp Studies
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Take a look at the key steps we take to conduct successful studies for complex drugs like Liraglutide.
Insights into the impact of Orally Inhaled Drug Products on driving the primary and secondary endpoints of COPD trials.