Regulatory Submissions

Regulatory Submissions

Our writers are focused on creating compliant documents that adhere to Good Clinical Practice (GCP) and the Declaration of Helsinki. With an awareness of regulatory standards, we 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 Efficacy (ISE)
  • Integrated Summary of Safety (ISS)
  • Investigator Brochures (IBs)

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)

Clinical Study Reports

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

Investigational New Drug Application

The INDA is the FDA’s first step in approving 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 study. 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

Patient Safety Narratives

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
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