Protocols, manuscripts, SOPs and submissions need to be clear and understandable to your target audience. We bring to bear many years of scientific, medical and regulatory writing experience to meet your needs. Our consultants have experience authoring a diverse array of documents for submission to the FDA and other regulatory agencies, as well as scientific manuscripts for submission to peer-reviewed journals.
Additionally, we can build quality systems from the ground up to ensure compliance at all levels of government oversight. Our quality assurance is second to none.
Our Services include
Pharmacokinetics/pharmacodynamics (PK/PD), toxicokinetics (TK), and population PK reports