From dossier preparation to global product registration โ we handle every aspect of pharmaceutical regulatory compliance with precision and expertise.
Complete Common Technical Document preparation as per ICH M4 guidelines โ Modules 1 to 5, including administrative, quality, non-clinical, and clinical documentation.
ASEAN Common Technical Document preparation for Southeast Asian markets โ tailored for Malaysia, Philippines, Thailand, Vietnam, and other ASEAN countries.
End-to-end pharmaceutical product registration support in 35+ countries, including dossier compilation, authority liaison, and approval tracking.
Strategic regulatory guidance for product development, market entry planning, regulatory gap analysis, and compliance strategy across global markets.
Comprehensive regulatory support for Africa, Middle East, CIS, Asia, Europe, and Latin American markets with country-specific documentation expertise.
No Objection Certificate documentation for Gujarat and other state drug authorities โ complete application preparation and submission support.
Expert assistance with CDSCO Sugam Portal registrations โ new drug applications, import licenses, manufacturing licenses, and online submission support.
Certificate of Pharmaceutical Product documentation โ preparation, notarization support, and apostille assistance for international product registration.
Complete pharmaceutical export documentation โ Free Sale Certificate, GMP Certificate, COPP, and country-specific regulatory document support.
Stability protocol design and documentation as per ICH Q1A-Q1F guidelines โ real-time and accelerated stability study documentation support.
Process validation, cleaning validation, analytical method validation, and equipment qualification documentation as per GMP requirements.
Batch Manufacturing Records, Batch Packaging Records, and Master Formula Records preparation compliant with Schedule M and GMP standards.
Standard Operating Procedure development for all pharmaceutical manufacturing departments โ production, QC, QA, warehouse, and regulatory affairs.
Pharmaceutical Site Master File preparation as per WHO and EU GMP guidelines โ comprehensive facility documentation for regulatory submissions.
Manufacturer sourcing, vendor evaluation, loan license documentation, and third-party manufacturing agreement support across India.
Pre-submission gap analysis and readiness assessment to identify documentation gaps before regulatory submission for any target market.
Drug Master File preparation and Active Pharmaceutical Ingredient documentation for regulatory submissions across global health authorities.
Country-specific pharmaceutical artwork and label design โ compliant with local language, regulatory, and pharmacopoeia requirements.
Our regulatory expertise spans across all pharmaceutical dosage forms, product categories, and industry segments.