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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

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.

Key Points to Keep in Mind as A Regulatory Submission Professional?

Why Choose ADI for Regulatory Submissions?

Contact us today to learn more about our regulatory submission services and how we can support your drug development journey.