Complete Documentation & Regulatory Compliance for Global Pharma Markets
Launching a pharmaceutical product in any international market demands precise, compliant, and well-structured regulatory documentation. At [Your Company Name], we offer expert services in dossier preparation and regulatory support following both CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) formats.
Our team of regulatory affairs professionals and documentation specialists ensures that your product files meet the latest guidelines from WHO, USFDA, EMA, MHRA, TGA, and ASEAN regulatory bodies. Whether you’re targeting registration in Asia, Latin America, CIS, Africa, or Europe, we provide end-to-end dossier development and submission support to accelerate your approval timelines.
✅ Our CTD & ACTD Regulatory Services Include:
- Complete Dossier Preparation
Compilation and formatting of Module 1 to Module 5 (CTD) or Part I to IV (ACTD), including administrative, quality, non-clinical, and clinical documents. - Country-Specific Dossier Customization
Adapting the dossier as per regulatory authority requirements of India, Philippines, Vietnam, Myanmar, Nigeria, Kenya, Brazil, and more. - Regulatory Gap Analysis
Review and audit of existing documents to identify deficiencies, missing data, or non-compliant sections before submission. - Query Handling & Deficiency Response
Full support in drafting response letters to regulatory queries, deficiency letters, and clarifications. - Lifecycle Management
Post-approval support including variations, renewals, updates, and labeling changes in line with regulatory expectations.
📚 Expertise in Multiple Product Categories:
- Generic Formulations (Tablets, Capsules, Injectables, Syrups)
- Herbal & Ayurvedic Medicines
- Nutraceuticals & Food Supplements
- Medical Devices & Cosmetics
- APIs & Bulk Drugs
🌍 Who We Support
- Pharmaceutical Manufacturers
- Exporters & Third-Party Marketers
- Contract Research Organizations (CROs)
- Nutraceutical & Herbal Companies
- Regulatory Consultants & Distributors
🛠️ Our Technical Team Offers:
- ICH-compliant CTD structure for EU and ROW markets
- ACTD formats for ASEAN countries and MENA region
- Translation and localization of regulatory documents
- Electronic CTD (eCTD) publishing and validation
- DMF (Drug Master File) & Site Master File preparation
💬 Fast, Compliant & Efficient Dossier Solutions
Whether you are registering your product for the first time or expanding into new global markets, our regulatory support team ensures speed, accuracy, and compliance at every step. We help minimize delays, avoid rejections, and streamline your product launch process.
👉 Get in touch today to discuss your dossier preparation needs or regulatory challenges.
Let’s bring your product to the global market—with confidence and compliance.