Regulatory Writing: Precision and Compliance with International Standards

Regulatory writing is essential to ensure that technical and scientific documents meet the requirements of national and international regulatory agencies. A rigorous process, based on global standards, guarantees the clarity, accuracy, and compliance of critical information.

Functions of Regulatory Writing

Regulatory writing plays a key role in the approval of clinical studies and compliance with medical and pharmaceutical product regulations.

Investigator Brochure

Clinical Study Reports

Research Protocols and Reports

Reference Annotations (Anchor) for Promotional and Non-Promotional Materials

International Experience

Over 20 successful projects since January 2023

Clients from various countries including:

Testimonials

Take a look at what medical and scientific writing has delivered:

“Angela has excelled as a medical editor, playing a crucial role in supporting our regulatory affairs department. Her commitment to achieving exceptional results while maintaining a high standard of work is noteworthy. Angela demonstrates impressive attention to detail and adept problem-solving skills, ensuring quality and accuracy in all her contributions. I highly recommend Angela to any team seeking excellence and reliability based on her exemplary performance.”

Thais Souza

Vice President, Project Management at Klick Health Latam

“Working with Angela was highly beneficial. Her precise and clear articulation of complex information significantly enhanced the project. I appreciate her professionalism and punctuality in delivering the work. I recommend her to anyone looking for writing assistance and support!”

Sebastian Vernal

MD, PhD, Infectologist

“I have worked on reviews, scientific article writing, editing, and formatting of scientific papers with Dr. Angela. Her work is impeccable and of great quality, from the moment of the first contact for a quote to the delivery of the final work. I recommend her for being extremely professional, punctual in deliveries, and proactive.”

Franciane Bobinski

Associate Professor at the University of Southern Santa Catarina (UNISUL)

“Angela is an exceptional specialist with a strong background in neuroscience and pharmacology. Her extensive research skills, combined with her utilization of AI tools, make her a valuable asset. Highly recommended for collaborative projects in advancing scientific discoveries.”

Scientific / Formula Review (Upwork)

My Work Process

My Process is Simple and Clear

Complete Understanding of the Project

• Analyzing the scope and regulatory requirements to define the best approach.

Presentation of a Clear and Objective Proposal

• Detailed description of the project scope, deliverables, and costs for full transparency.

Project Development with Rigor and Precision

• Creation of documents aligned with required regulatory guidelines and standards.

Review and Adjustments Based on Feedback

• Incorporation of improvements based on client and regulatory agency reviews.