Regulatory Writing
Learn the Art of Effective Regulatory Drafting
Regulatory writing is a specialized field of documentation that is essential for regulatory registration to the government, such as to the FDA (Food and Drug Administration), EMA (European Medicines Agency), etc. It involves creating clear, concise, and scientifically accurate documents that meet the specific requirements of regulatory authorities.
At ADI, we understand the importance of regulatory submissions in the drug development process. Our team of expert writers is dedicated to creating high-quality, compliant documents that adhere to Good Clinical Practice (GCP) and the Declaration of Helsinki.
Our Team Of Experts Handle the Documentation For
- Investigational New Drug Application (INDA)
- Clinical Study Reports (CSRs)
- Safety and Risk Management Documents
- Clinical Trial Protocols
- Patient Safety Narratives (PSNs)
- Statistical Analysis Plan (SAP)
- Common Technical Document (CTD)/Electronic Common Technical Document (eCTD)
- Labeling and Package Inserts
- Regulatory Consulting
- Clinical Evaluation Report (CER)
- Informed Consent Form (ICF)
- Integrated Summary of Safety (ISS)
- Investigator Brochures (IBs)
- Document-level publishing of CSR
Major Regulatory Submission Services By ADI
The ICH GCP-compliant protocols ensure progress in the clinical phase of drug development. Our specialists can help with
- Protocol conceptualization for every phase
- Protocol customization (meet regulatory and sponsor requirements)
- Protocol design (collection of quality data and pragmatic delivery of clinical trials)
To magnify the impact of CSR and increase the chances of FDA approval, we formulate fully optimized and well-organized CSRs for the finest written CTDs we provide.
- CSRs created after collaborating with scientific experts
- Clear and concise writing with regular QC checks
- Full/ Abbreviated/ Synoptic CSRs
- Document-level CSR publishing
The INDA is the FDA’s first step in approving phase 1 clinical trials, phase 2 and phase 3 clinical trials. This initial trial step and subsequent trial documentation take considerable time and effort to ensure consistency among documents. We offer:
- IND planning and execution
- Commercial IND
- Research IND (Non-commercial)
- IND annual reports
Our SOP solution approach is to develop bespoke plans for your clinical operations, monitor feasibility, and manage projects, allowing us to pinpoint critical areas. We create SOPs for
- Regulatory document submission
- Scientific documents
- Data management
Our clinical data handlers utilize their knowledge to produce clear and concise ICFs that cover all the essential elements of a protocol or preclinical studies. We develop ICFs that consist
- Patient-understandable language (clear and plain)
- Disclosure of key information
- Documentation of consent
- A balanced presentation of benefits and risks
Narratives add momentum to the current state of development, allowing clients to provide better diagnoses and devise better solutions. We deliver a large batch of narratives in a short period. Narratives crafted by us are
- Compliant with the ICH E3 guideline
- Maintained quality, consistency, and standardization
- Regular review feedback
Our document-level publishing service for Clinical Study Reports (CSRs) ensures that your regulatory submissions are presented in a clear, organized, and easily navigable format. This process involves:
- PDF conversion and document formatting
- Creation of bookmarks and hyperlinks for seamless navigation
- Generation of a detailed Table of Contents (ToC)
- Pagination of documents according to agency specifications
- Setting of document properties to meet ICH criteria and regulatory requirements
By providing a user-friendly and easily accessible CSR, we make it easier for regulatory reviewers to navigate and review your document, ultimately streamlining the approval process.
- Protocol conceptualization for every phase
- Protocol customization (meet regulatory and sponsor requirements)
- Protocol design (collection of quality data and pragmatic delivery of clinical trials)
To magnify the impact of CSR and increase the chances of FDA approval, we formulate fully optimized and well-organized CSRs for the finest written CTDs we provide.
- CSRs created after collaborating with scientific experts
- Clear and concise writing with regular QC checks
- Full/ Abbreviated/ Synoptic CSRs
- Document-level CSR publishing
The INDA is the FDA’s first step in approving phase 1 clinical trials, phase 2 and phase 3 clinical trials. This initial trial step and subsequent trial documentation take considerable time and effort to ensure consistency among documents. We offer:
- IND planning and execution
- Commercial IND
- Research IND (Non-commercial)
- IND annual reports
Our SOP solution approach is to develop bespoke plans for your clinical operations, monitor feasibility, and manage projects, allowing us to pinpoint critical areas. We create SOPs for
- Regulatory document submission
- Scientific documents
- Data management
Our clinical data handlers utilize their knowledge to produce clear and concise ICFs that cover all the essential elements of a protocol or preclinical studies. We develop ICFs that consist
- Patient-understandable language (clear and plain)
- Disclosure of key information
- Documentation of consent
- A balanced presentation of benefits and risks
Narratives add momentum to the current state of development, allowing clients to provide better diagnoses and devise better solutions. We deliver a large batch of narratives in a short period. Narratives crafted by us are
- Compliant with the ICH E3 guideline
- Maintained quality, consistency, and standardization
- Regular review feedback
Our document-level publishing service for Clinical Study Reports (CSRs) ensures that your regulatory submissions are presented in a clear, organized, and easily navigable format. This process involves:
- PDF conversion and document formatting
- Creation of bookmarks and hyperlinks for seamless navigation
- Generation of a detailed Table of Contents (ToC)
- Pagination of documents according to agency specifications
- Setting of document properties to meet ICH criteria and regulatory requirements
By providing a user-friendly and easily accessible CSR, we make it easier for regulatory reviewers to navigate and review your document, ultimately streamlining the approval process.
Key Points to Keep in Mind as A Regulatory Submission Professional?
- Regulatory writers must have a strong understanding of scientific and medical terminology, as well as knowledge of regulatory guidelines and requirements.
- They often collaborate closely with subject-matter experts, such as scientists, clinicians, and regulatory framework professionals, to ensure the accuracy and completeness of the documents they produce.
- Additionally, regulatory writers must adhere to strict timelines and formatting guidelines to meet their submission deadlines.
Why Choose ADI for Regulatory Submissions?
- Expertise in regulatory framework and guidelines
- High-quality, compliant documents
- Timely delivery and project management
- Collaboration with scientific experts
- Customized solutions for your clinical operations
Contact us today to learn more about our regulatory submission services and how we can support your drug development journey.