Products
Regulatory intelligence reports
Regulatory intelligence reports are produced after scanning the regulatory horizon. They often contribute to company decision-making. For example, a regulatory intelligence report might help a company decide on the order in which to register their product in global regions. Or these reports might help determine what text is required in artwork for an area.
Case study: A USA-based company was developing an analyte-specific reagent (ASR) for a genetic disease. They wanted a regulatory intelligence report to understand ASR regulation in global regions and what regulatory strategy they should follow to market their product. I worked with three others to prepare a regulatory intelligence report on ASRs. We learned ASRs are regulated as laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs) depending on the application and the world region. The regulatory intelligence report provided key company stakeholders a strategic approach to market their product worldwide.
White papers
White papers are research-based reports where complex information is presented in easy-to-digest ways to provide state-of-the-art information to key stakeholders. For example, information concerning a product and the disorder it treats.
Case study: A biotechnology company was developing a product to treat a pain disorder caused by a genetic disease. The company wanted scientific writing for a white paper. I listened to the company laboratory team and got their input, I analysed available scientific literature, and thoughtfully considered how their product could enhance the state-of-the-art treatment and apply to other parts of the neurological system that had been left untreated. The white paper gave key company stakeholders ideas about developing their product.
Quality management system (QMS) documents
QMS documents define an organisation's processes, procedures, and responsibilities to improve company operations, customer satisfaction, and company reputation. Company departments must have quality management documents like standard operating procedures (SOPs) that can be reviewed during regulatory inspections.
Case study 1: A biotechnology company was developing its quality management system (QMS). The company wanted important documents for their procedures. I worked with two others to prepare documents, including a quality manual, standard operating procedures (SOPs), audit templates, and audit meeting documents. The number of documents we needed to prepare required us to take a flexible approach to their outlines and how we worked together to complete the project. The biotechnology company became a repeat customer.
Case study 2: I worked at a pharmaceutical manufacturing site and aligned with Bulk Production, the Tank Farm, and the Raw Materials Store. I was routinely asked to update procedures that required input from cross-functional subject matter experts (SMEs), including Quality Assurance, Bulk Production (including the Tank Farm and the Raw Material Store personnel), Quality Control Laboratory, and the Material Science and Technology (MSAT) department. I worked with various personnel to update the Production SOPs, logs, and forms as needed. Updating these documents on time helped to ensure controls and manufacturing site compliance.
Common technical document (CTD) sections
A company prepares a CTD for product dossier submissions to global regulatory authorities. The CTD format is considered globally and specifies regional administrative information, non-clinical and clinical outputs, and quality.
Case study: I joined a rare disease biotech company team. They wanted me to write non-GLP CTD Module 2.4 and 2.6 documents for their regulatory submissions. I worked on the CTD Module 2 non-clinical content, which included a non-clinical overview, an introduction, and written and tabulated summaries for pharmacology, pharmacokinetics, and toxicology sections. I had weekly meetings with the biotech company's Head of Regulatory Affairs. I have done repeat work with the same biotech company, and they have given me good feedback on how I work. I wrote white papers for the same biotech company for a different product the previous year.
Slide deck presentations
Slide decks are often prepared for training purposes. They can be used to prepare personnel for regulatory inspections, manufacturing operations, and product distribution requirements.
Case study 1: When I worked in quality assurance (QA) departments, I was frequently asked to provide training to other company department personnel. I gave training concerning procedure updates, various GxPs, and the science relating to the product. I gave training to rooms of up to thirty personnel using PowerPoint presentations that I prepared. This resulted in the trainees having more awareness of how their jobs impact patient lives.
Case study 2: A Big Pharma company was organising a clinical trial key opinion leader (KOL) meeting. KOLs prepared PowerPoint slide decks, and the Big Pharma company wanted a review with attention to detail of each KOL presentation to ensure uniform formatting and valid referencing. I worked with another person, where we applied attention to detail to review each slide deck. The Big Pharma company in-house oversaw what we provided them and was happy with our output.
