Technical Writing
Meet GMP documentation requirements and deadlines in a cost-effective manner, with reduced disruption of day-to-day operations.
Quality & Compliance technical writing services ensure:
  • Finished Standard Operating Procedures (SOPs) and related documents are clear, accurate and easy to use.
  • All documents are written in company's preferred style/format.
  • Work is completed quickly; our studies show that your staff saves (on average) 80% of the time it would take for them to generate the technical document themselves.
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  • Work is performed with minimal intrusion: most work is done off-site; office space, computers, support staff, are not required from client.
  • You avoid hiring new permanent or contract employees.
  • Your existing staff stays focused on regular business.
  • Impact on your bottom line is minimized.
We can write and/or revise documents for manufacturing, laboratory,
or general quality assurance operations, including:

• SOPs and policies   • Work instructions   • Quality records   • Specifications

For new documents, our technical writers collect background information and work with the subject matter experts (SMEs) to understand what is required. The SME may be management; often it is the shop floor operator or mechanic. Once a document is drafted, it is reviewed with the SME, and where appropriate (e.g., quality records, batch records), it is trialed on the shop floor prior to final review and approval. For all documents, our associates coordinate the review and approval process with all stakeholders to ensure everyone using the document and approving the document has an opportunity to provide feedback. We also offer SOP-based training on approved SOPs - go to our GMP Training page for more details.

For importers, distributors, and wholesalers of drug products, we can quickly and efficiently develop a Quality Manual (an interlinked system of SOPs and Quality Records) that is customized for your quality control processes. Go to Quality Control Officer services to learn more about our GMP Soloutions.

We can provide assistance in writing validation master plans, protocols, and supporting SOPs that satisfy regulatory requirements and meet your company's needs. Go to our Validation Services to learn more about our offerings.


  Our Services
Quality & Compliance Services Inc. (Q&C®) provides
expert assistance at every stage of a GMP compliance program. We have a team of full-time, dedicated, diversified, committed and knowledgeable specialists; our associates are assigned to a given project to meet a client's particular needs. Q&C® is able to flex to meet changing project scopes (e.g., tightened timelines, market changes, short-term workforce shortages, etc.).

Why Hire Us for
Technical Writing?
  1. By hiring us to complete your technical writing tasks, your staff will be able to focus on regular business. This, combined with our ability to complete the work quickly, means the impact on your bottom line is minimized. Our studies show that your staff saves (on average) 80% of the time it would take them to generate a technical document themselves.

  2. Much of this work can be performed off-site; office space, computers, and support staff, are not required. We communicate regularly with you and transfer documents via e-mail as they are ready for review.

  3. You will retain all documentation at the end of the project. We provide documents in your preferred format that are clear, accurate, and easy to use.
Other Services
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