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Phase I clinical trials, BE/BA study, general PK/PD

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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Biosimilars

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.

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Bioavailability & Dose Proportionality

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.

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Marketing & Promotional Practices

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

Greenleaf Health Inc. offers various services such as: Strategic guidance on labeling requirements; Promotional materials; Direct-to-consumer advertising review processnRemediation of untitled and warning letters; Use of social media.

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Supporting Drug Development at Phase IV

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Premarket Submissions

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

Greenleaf Health Inc. offers various services such as: 510(k) premarket notifications; Premarket approval applications (PMAs); Requests for de novo review of automatic Class III classification; Humanitarian use designation (HUD) / humanitarian device exemption (HDE) applications; etc.

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Phase lllb-lV

Clinical Trials >> Clinical Development / Phase IIb-IV >> Phase IV

PAREXEL® has provided world class Late Phase services for over a decade. This is why we know this part of your journey so well. We helped plan it.

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Non-compartmental PK & PD Analysis

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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PK / PD Modelling & Simulation

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical

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Toxicokinetic Analysis & Bioanalytical Data Review

Clinical Trials >> Clinical Development / Phase IIb-IV >> Pharmacokinetics / Pharmacodynamics / Pharmacometrics

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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