About Biotech Ink

Dr. Susan E. Caldwell

 

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Our services extend from early draft document development through final publication in electronic and/or paper format. You decide which of our services you want to use.

We provide writing, editing, content review, copyediting, proofreading, fact-checking, and document formatting services for our clients. Properly applied, these services culminate in the delivery of a complete, submission-ready product. Our document development capabilities include full submissions (eCTDs as BLAs, sBLAs, NDAs, INDs, and PMAs) to the US Food and Drug Administration and other regulatory agencies; clinical study protocols, reports, and amendments; investigator brochures; discovery and preclinical reports; pharmacokinetic (PK) and toxicology reports; clinical research materials (such as clinical study manuals and patient diaries); drug safety (eg, adverse event narratives); and process development and manufacturing (CMC) documentation.

If you are publishing electronically, we work with your publisher to ensure that your documents are ready for publication in the format and organization needed to be fully ICH compliant. Close communication between writers and publishers minimizes costly inefficiency and delay due to document rework, and this is particularly true with the eCTD submission format.

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