06·Consulting Practice 06
Scientific and Regulatory Documentation for Natural-Health Products
We prepare high-quality scientific and regulatory documentation for natural-health products — from regulatory dossiers and literature reviews to technical reports, product monographs and peer-reviewed manuscripts.
What This Practice Covers
Scientific and regulatory documentation is the foundation of every successful natural-product development project. Whether you are preparing a regulatory submission, building an evidence dossier, seeking publication or communicating your product's scientific basis to healthcare professionals, the quality of your documentation matters. Our scientific and medical writing practice provides expert documentation support across the full range of natural-product writing needs.
All documentation we prepare is based on the evidence and information provided by our clients and the published scientific literature. We do not fabricate data, misrepresent research findings or prepare documentation that overstates the evidence base for a product.
Scope of Practice
What We Provide
Regulatory Dossiers
Preparation of regulatory dossiers for AYUSH drug applications, FSSAI submissions, EU THMPD applications, TGA submissions and other regulatory pathways — including all required sections and supporting documentation.
Literature Reviews
Systematic and narrative literature reviews on natural-product ingredients, formulations and therapeutic areas — covering traditional use, pharmacology, clinical evidence, safety and quality.
Technical Reports
Technical reports on product development, formulation rationale, ingredient assessment, quality testing, stability studies and other technical aspects of natural-product development.
Product Monographs
Comprehensive product monographs covering botanical identity, traditional use, phytochemistry, pharmacology, clinical evidence, safety, quality standards and regulatory status.
Manuscript Preparation
Preparation of manuscripts for peer-reviewed publication — original research articles, review articles, case reports and short communications — on natural-product topics.
Safety and Efficacy Summaries
Structured summaries of safety and efficacy evidence for regulatory submissions — including expert reports, overview documents and evidence tables.
Traditional Use Documentation
Documentation of traditional use evidence — historical text references, ethnobotanical records, practitioner surveys and bibliographic evidence — in formats suitable for regulatory submission.
Scientific Communication
Scientific communication materials for healthcare professionals, researchers and informed consumers — including product information documents, evidence summaries and educational content.
Clients
Who This Practice Serves
Ready to discuss your documentation needs?
Contact us to explore how our scientific and medical writing practice can support your natural-health product programme.