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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.

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.

Human Repeat Insult Patch Test (HRIPT)

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

To determine the safety of topical products, RCTS provides a range of clinical testing procedures, including a broad range of in-use and patch studies. Human repeat insult patch tests (HRIPT) for contact sensitization/irritation and acute or cumulative patch tests irritation.

Premarket Preparation

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

Greenleaf Health Inc. offers various services such as: Combination product designations; Requests for device classification (513(g)); Presubmission strategy; Identification of predicate devices; Determination of and compliance with performance data and labeling requirements; etc.

Clinical Development Services & Solutions

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

Chiltern provides the following services for Phase lllb - IV Post-marketing Late-stage programs: Post-approval GCP studies, Disease, product and pregnancy registries, Epidemiological studies, Restricted access and compassionate use programs, Retrospective and chart extraction studies, Risk

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.

Clinical Development Services & Solutions

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

Chiltern provides the following services for Phase I - lla Patient Studies early stage programs: Protocol feasibility and design, CRF development, Recruitment, Data management, Bioanalytical, Biostatistics

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

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.

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.

PharmaCompass