Regulatory Medical Writing

Expert Medical Writing in Clinical Research

01Medical Writing

Expert Medical Writing in Clinical Research

Our Medical Writing Services provide high-quality, scientifically accurate documentation for clinical trials, regulatory submissions, and scientific publications.

We specialize in delivering clear, concise, and compliant documents tailored to meet the needs of pharmaceutical, biotechnology, and medical device companies. Our expertise ensures your documentation supports the successful approval of your product.

Clear, concise and compliant documents for pharma, biotech and device companies

Documentation, submission ready

Features

Core Documents
Regulatory & Publication
ICH E3 Standard

Document types

CSRClinical Study ReportsICH E3 structure
BECS-BE SummariesBioequivalence
INDRegulatory SubmissionsINDs, CTAs, NDAs, BLAs
IBProtocols & Investigator BrochuresStudy start-up
FDAFDA Summary TablesANDA submissions
ROWDossier DevelopmentRest of World markets

Core document services

Our medical writers work closely with your team so every document is scientifically accurate, meets ICH, FDA and EMA standards, and supports your business objectives.

Integrated study reportseCTD
Hyperlinking & bookmarkingeCTD
FDA summary tablesANDA

Regulatory & publication support

Trained statisticians, programmers and writers deliver data analysis and statistical reporting in full compliance with international guidelines, through to publication.

Standards

ICH E3
FDA
EMA
eCTD
ICH

Written to minimise delays

Reports conform to ICH E3 “Structure and Content of Clinical Study Reports”, written to minimise possible delays in regulatory approval.

Core Document Services

Our experienced medical writers work closely with your team to ensure all documents are scientifically accurate, meet global regulatory standards (ICH, FDA, EMA), and support your business objectives.

Clinical Study Reports (CSRs) and Bioequivalence (CS-BE) Summaries
Regulatory Submissions (INDs, CTAs, NDAs, BLAs)
Protocol and Investigator Brochure (IB) Development
FDA Summary Tables for ANDA Submissions
Dossier Development for ROW (Rest of World) Markets

Regulatory & Publication Support

Our team, comprising trained statisticians, programmers, and writers, ensures high-quality data analysis and statistical reporting in full compliance with international guidelines. We specialize in:

Integrated study report writing in eCTD format with hyperlinking and bookmarking.
Preparation of abstracts, manuscripts, and poster presentations for publication.
Experienced-based study protocol and ICF (Informed Consent Form) development.
Custom format reports and patient narratives.
CD-ROM and hard copy delivery of reports and associated study data.

Our standard reports are meticulously prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports". Our regulatory expertise ensures documentation is written to minimize possible delays in regulatory approvals, a crucial factor in successful medical writing in clinical research.

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Regulatory Medical Writing

Expert Medical Writing in Clinical Research

Documentation, submission ready

Core document services

Regulatory & publication support

Written to minimise delays

Core Document Services

Regulatory & Publication Support

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