Mastery in Chemistry, Manufacturing, and Controls Technical Writing & Electronic Publishing
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At Syner-G, our tailored services are designed to navigate the complexities of drug development and regulatory submissions, ensuring your products reach the market with precision and efficiency. This includes regulatory Chemistry, Manufacturing, and Controls (CMC) document preparation, technical writing, and electronic publishing services.
Regulatory CMC Technical Writing – The Keystone of Your Regulatory Submission
At Syner-G, we understand that CMC technical writing is not just about meeting regulatory requirements; it’s about mastering them. Our CMC technical writing services stand at the intersection of science and compliance, providing you with clear, accurate, and comprehensive documents that reflect the quality and integrity of your product.
Precision and Expertise
Our team of skilled CMC technical writers brings together a wealth of experience from the pharmaceutical and biotechnology industries. They possess the scientific understanding and regulatory knowledge necessary to prepare succinct documentation that speaks directly to the concerns and expectations of regulatory authorities.
Customized Documentation
Whether it’s an Investigational New Drug Application (IND), Investigational Medicinal Product Dossier (IMPD), a New Drug Application (NDA), a Biologics License Application (BLA), or a Marketing Authorization Application (MAA), our CMC documents are meticulously crafted to support your product’s unique attributes. We tailor each document to your specific needs, ensuring that every submission is as robust as it is compliant.
Full-Spectrum Regulatory CMC Technical Writing Services
- Document management services including organization of source documents and set up of submission folders with templates
- Development and integration of key messages
- Module 2.3 (QOS) and Module 3 of the Common Technical Document (CTD)
- Drug Master Files (DMFs)
- Compliance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and Common Technical Document for the Registration of Pharmaceuticals for Human Use (M4Q) requirements
- eCTD compliant document preparation and stylistic formatting
Each document is a cog in the complex machinery of regulatory approval, and we ensure every cog is well-oiled and integrated for optimal performance.
Electronic Publishing – Your Passport to Global Regulatory Compliance
In today’s digital era, electronic submissions are a fundamental requirement for regulatory agencies worldwide. Syner-G’s electronic publishing services are designed to ensure that your eCTD submissions meet the stringent technical standards set forth by regulatory authorities.
Seamless eCTD Submissions
Our team of electronic publishing specialists uses state-of-the-art software and adheres to the latest eCTD guidelines to create, compile, and submit your documents. We guarantee a seamless submission process, with fully compliant eCTD sequences that facilitate a smooth review by health authorities.
Agile and Adaptive Processes
Understanding that regulations and technologies evolve, Syner-G is committed to agility and adaptability. Our processes are designed to be responsive to changes in regulatory requirements and technological advancements, ensuring your submissions are always at the forefront of compliance.
Comprehensive Electronic Publishing Services
- eCTD formatting and compilation
- Hyperlinking and bookmarking of documents
- Lifecycle management of eCTD sequences
- Validation against current regulatory specifications
- Submission to regulatory agencies, including the FDA, EMA, Health Canada, and others
With Syner-G, you gain a partner with a commitment
To excellence in every aspect of CMC technical writing and electronic publishing. Our approach is proactive, thorough, and backed by a profound understanding of the pharmaceutical landscape and regulatory expectations.
When you choose Syner-G, you choose a path that leads to success. Partner with us and let our expertise in CMC technical writing and electronic publishing pave the way for your product’s success in the global marketplace.