Latika Rana-Afi

Latika Rana-Afi is a regulatory medical writer specializing in clinical trials, biotech, and pharmaceutical teams. She authors and edits core regulatory documents such as clinical study protocols, investigator's brochures, clinical study reports, and eCTD content. The work adheres to ICH, ICH-GCP, MHRA, FDA, and ISO standards, ensuring documents are audit-ready and compliant.

The business offers services for clinical and regulatory teams, including drafting core clinical and regulatory documents from protocols and statistical outputs. Services include consistency checks, quality control, version control, and compliance review to align with MHRA, ICH, and FDA expectations. Additionally, they provide eCTD and CTD module content preparation, coordination of review cycles, and drafting responses to regulatory questions.

Clients can start a project by visiting the website and clicking the 'Start a project' button. The engagement is remote, and the writer is based in the UK. The status is open to new projects, allowing teams to initiate collaborations for their regulatory document needs.

The business operates remotely and is based in the UK, serving clients globally. The website explicitly states that the engagement is remote, facilitating collaboration across different locations while maintaining compliance with international standards.

The business adheres to several key standards, including ICH E3, ICH E6 (GCP), ICH E8, MHRA, US FDA, and ISO. These standards ensure that the documents produced are consistent with regulatory expectations and audit-ready.

The business handles various document types, including clinical study protocols, protocol amendments, investigator's brochures, clinical study reports, schedules of activities, and eCTD/CTD module content. Each document is written to its governing standard to ensure clarity and operational consistency.

The business provides structured literature reviews, evidence synthesis, and data summarization to underpin regulatory narratives. These services help build clinical rationale and benefit-risk arguments for clinical and regulatory teams.

The business prepares eCTD and CTD module content, coordinates review cycles and timelines, and drafts responses to regulatory questions. This support keeps the submission package moving toward final approval.

The business offers a range of services from a single document to an end-to-end submission package. Each service is tailored to the specific needs of the client, ensuring comprehensive coverage of the clinical and regulatory lifecycle.

The business can be contacted via the website at latikarana-afi.com or by phone at +447526773538. The website also provides an email contact for inquiries and project initiation.

The official website of Latika Rana-Afi is latikarana-afi.com.

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