Strategic Document Planning

We are experts in the scientific, regulatory, and industry requirements of all of the types of documents that are necessary for the clinical development and registration of your product. We work closely with you to design documents that will meet the highest scientific, regulatory, and industry scrutiny. We also work closely with you to determine your key messages and to ensure that these are conveyed accurately, consistently, and clearly across all of the documents in your clinical development and registration programs. In a nutshell, we write documents that are targeted to your audience in a clear, concise, and consistent manner.

Medical Writing

We have extensive knowledge and hands-on writing experience with all types of clinical documents from early to late development, as well as post-approval, including registration-related documents, manuscripts, and presentations. Our writing experience includes:

• Clinical Study Reports
• Patient Narrative Summaries
• Investigator Brochures
• Investigational New Drug (IND) Applications
• US New Drug Applications (NDAs)
• EU Marketing Authorization Applications (MAAs)
• Safety Update Reports
• Briefing Documents for Regulatory Agencies
• Responses to Regulatory Agencies
• Advisory Committee Brochures
• Manuscripts
• Presentations

Process Management

We can manage all aspects of the writing process, including author relationships, timelines, and crises associated with changing timelines and priorities.

Our Advantage

Diverse Experience in Global Clinical Development

Our diverse document experience, therapeutic experience, and our knowledge of global clinical development give us the expertise that we need to help you to reach your goals. Our therapeutic experience includes:

• Analgesia
• Cardiovascular Diseases
• CNS Diseases
• Endocrinology
• Hair Growth
• Infectious Diseases
• Oncology
• Urology
• Women's Health

Attention to Detail

We demonstrate an intense attention to detail with regard to the scientific content and regulatory guidelines, as well as to specialized medical vocabulary, consistency in terminology and key concepts, and correct grammar and syntax. We promise that the documents that we write will meet the highest professional standards for writing quality, while at the same time conveying the complex data that your documents require.

Commitment to Teamwork

We know that trust, communication, and shared accountability are key components of success. We view teamwork as an integral part of everything that we do and will partner with you to ensure that your goals are met in an atmosphere that best suits your working style.

Innovative Solutions

We have good organizational skills, are creative, and have a professional approach—qualities that are necessary to produce the perfect document. We maintain flexible working practices and systems that allow us to rapidly accommodate your needs. We continuously work to develop innovative technologies and efficiencies in an effort to reduce costs and save time, without sacrificing quality.