Swan International

Regulatory Tools & Medical Writing

Regulatory Tools

We can provide following regulatory documents:

✔ Check list of documents in line with prevalent regulatory submission guidelines for Marketing Authorization Application across Globe.

✔ Guidance documents for PV, Co-validation, BE, Dissolution profile, CTA and MAA for Brazil, WHO and other markets.

✔ Global Regulatory Information Sheet covering Critical Parameters i.e. Batch Size & Stability data requirements, Timeframe for Approval, Types of submission, Applicable fees and major regulations.

Medical Writing

We provide a range of medical and scientific writing services. It covers:

✔ Investigational Medicinal Product Dossier (IMPD)

✔ Submission modules (CTD Modules 2.4, 2.5, 2.6, 2.7, Module 4 & Module 5)

✔ Patient Information Leaflet and SmPC

✔ Expert reports

About Swan International

Swan International is a young company engaged in the development, registration, manufacture and marketing of Pharmaceutical products in Asia, CIS, Eastern Europe and Africa countries. Our commitment is to bring innovative products at affordabale prices to serve community in best possible way.

Contact Us

Address : Swan International B-wing, 7th Floor, Chedda CHSL, MG Road, Charkop Village, Charkop, Kandivali (West) Mumbai - 400067, Maharashtra, India
Phone : +91 97025 11106 / +91 86520 07139

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