Consulting

Our experienced consultants can review your existing document and submission authoring  processes. Redthread consultants provide guidance on the authoring of regulatory documents tailored to your company needs. Our consultants work with you to engineer changes through the writing of standard operating procedures (SOPs), working practices and instructions, in addition to the provision of in-house training on new processes.

Redthread consultants can advise you on any, or all of the writing steps involved in dossier creation, conversion and lifecycle management. Our consultants consider regulatory requirements that are specific to your product, the target market, the submission type and the submission format.

Use our management support to provide ad hoc, part-time or interim management of your projects, teams or outsourcing.

Our client needed to optimise the authoring and production of Investigator Brochures (IB).

Red Thread recognised that this was a company-wide issue. The problem was not limited to tools, but required an assessment of the interaction of operational functions within the organization.

Our consultants reviewed the IB documents for each product, the client’s existing process and interviewed each functional stakeholder. We were able to identify areas for improvement and continued to work with the client to implement of our recommendations.