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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.
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.
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.
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
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.
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
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
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.
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.