Syner-G recognizes the critical role of high-quality, regulatory-compliant medical writing services for healthcare and pharmaceutical advancements. Our team of seasoned medical writers excel in producing clear and concise scientifically accurate documents.
Specializing in a broad spectrum of regulatory documents, including clinical study reports, Investigator Brochures, and marketing applications like NDAs and BLAs, Syner-G has contributed to over 50 successful applications. Our commitment to excellence guarantees that each document meets the rigorous standards of scientific and regulatory precision, supporting our clients in bringing new treatments and medical therapies to market efficiently and effectively.
Comprehensive Document Preparation Services
Our medical writing expertise encompasses a wide array of document types essential for regulatory submissions and scientific communication. With proficiency in the document development phase, we ensure that each document is crafted with precision, supporting our clients through the drug development process and regulatory approval.
Our medical writing services include:
Extensive Experience and Expertise
Our medical writing team, composed of medical writing experts, distinguishes itself through extensive experience, which spans a wide range of therapeutic areas. Our systematic approach to each task ensures that every document produced is of the highest quality and precision. This depth of knowledge allows us to offer comprehensive support for a variety of regulatory documentation needs, tailored to the specific requirements of each project.
Therapeutic Areas and Development Phases
With broad medical writing skills, we are adept at addressing the unique challenges and nuances of each field. Our expertise in clinical research is evident in every document produced, reflecting our commitment to excellence in every phase of development.
From early-stage research to late-phase clinical trials, our writers have experience navigating the complexities of drug development. This versatility guarantees that we can provide high-quality, scientifically sound documentation that meets the stringent requirements of regulatory agencies worldwide.
Variety of Regulatory Documents
The scope of our work encompasses various regulatory documents, each critical to the success of our clients’ projects:
Clinical Study Reports (CSRs)
We produce detailed reports that clearly present the findings of clinical studies, meeting global regulatory guidelines.
Clinical Protocols
Our team designs comprehensive protocols that outline the objectives, design, methodology, statistical considerations, and organization of clinical trials.
Investigator Brochures
Investigational New Drug (IND) Applications
Procedures Developed to Maintain the Highest Quality Control
Our standard operating procedures are in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients. We prepare your documents using our suite of ICH-compliant templates and style guide or using sponsor-provided materials. Our team produces high-quality documents with a focus on formatting and style, as well as scientific communications and content.
Through our commitment to excellence and our extensive experience, Syner-G’s medical writing team makes sure that all documents are crafted to facilitate the smooth progress of drug development programs and support successful regulatory submissions.
Following submissions of NDAs and BLAs in the US, we are frequently asked by our clients to assist them in authoring Briefing Documents in support of FDA Advisory Committee Meetings.
Unmatched Proficiency in Marketing Applications
Authoring Clinical Components
By meticulously detailing the safety, efficacy, and quality of investigational products, we facilitate a smoother review process and enhance the likelihood of approval.
A Track Record of Success
Each application we support benefits from our strategic insights and tailored approach, ensuring that the clinical evidence is presented in the most persuasive manner possible.
Engage Our Expertise
Syner-G is dedicated to advancing your pharmaceutical projects with our specialized medical writing services. Our experienced medical writers, many with advanced degrees, guarantee quality and are ready to provide the services and support necessary to navigate the complexities of regulatory documentation and submissions.
If you are seeking unparalleled precision, clarity, and regulatory insight in your medical writing needs, connect with us. Let’s discuss how we can contribute to the success of your projects and accelerate the journey of your products from development to market. Contact us today to explore our services and start a collaboration that transforms your challenges into achievements.
Our Fellowship Program
Our Medical Writing Fellowship Program is for medical writer professionals looking to gain experience in the medical/regulatory writing field. Fellows will be exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics.