More about Pharmakey Document/Report Level Publishing Services

Authoring Templates

Pharmakey can provide sponsors with MS Word authoring templates, including an authoring toolbar for module 2 summaries and module 3 drug substance and drug product sections. These templates ensure that submission documents are authored to the appropriate eCTD granularity and include the appropriate content subsections. Templates for clinical study reports are also available.

Standards Documents

Pharmakey has developed generic standards documents that can be used as is or used as a starting point to accelerate establishing sponsors desired formats and standards. These documents include a style guide, bookmarking and hyperlinking standards and preparing literature references for electronic submissions.

Document/Report Publishing

Pharmakey can help sponsors accelerate the document preparation process by taking over many document level publishing tasks. Document level publishing by Pharmakey ensures that documents will be prepared to both sponsor and regulatory authority requirements and specifications. Pharmakey document publishing services include:

Quality Control

Quality Control processes are run on every document through the publishing process. The final QC process is conducted by a publisher that has not previously worked on the document.

Document/Report Publishing SOPs

Pharmakey maintains document and report publishing Standard Operating Procedures to ensure a consistent, uniform and high quality electronic document while maintaining the flexibility needed for the diverse source documents common to small pharmaceutical and drug development companies.