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

• Clinical pharmacology study protocol

• Clinical study report (CSR)

• Investigational New Drug (IND) Application

• New Drug Application (NDA)

• Biologics License Application (BLA)

• FDA meeting request and briefing package

• Orphan drug application

• Pediatric Study Plan (PSP)

• Medical manuscript or journal article