Keypharma - Problem Solving Keys - Product and Formulation Development

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Our Services

Technical skills,
process know-how,
creativeness

Product & Formulation Development

Development of new pharmaceutical formulations and technologies, contacts with Experts and academic or industrial centers of biopharmaceutics and pharmacokinetics, biopharmaceutical and formulation studies, statistical analysis of population kinetics, in vitro simulations and studies, modified release and bioavailability enhancement studies are the Project Management activities traditionally offered by KEYPHARMA, in addition to “traditional” phase I-IV clinical development projects.

Besides KEYPHARMA is now able to provide two innovative and modular formulas.

Early Due Diligence (EDD)

A modular series of services aimed at guaranteeing the formal and scientific quality of trial results:

Analysis of the protocol and key submission documents
Scientific advice (formal or informal)
Assessment of “critical issues” of the protocol and/or procedures
Site Qualification
Site compliance audits, evaluation of potential corrective actions, compliance reports

StartRight

A modular series of services for real time planning of optimal registration strategy in the initial phase of clinical development:

Reverse Planning
Analysis of literature
Main and Surrogate endpoints
Modeling (PK, PD, trial design, trial optimization)
Scientific advice (formal and informal)

Newsroom

EC: information to patients and Pharmacovigilance - New developments

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