Global Market Extension and Regulatory Filing Services
Introduction:
Our pharmaceutical consulting services specialize in facilitating market extensions and regulatory filings in countries around the world. Whether in regulated or non-regulated markets, we provide comprehensive support for product registrations, approvals, and compliance, ensuring a smooth entry into diverse global markets.
Details
Regulated Markets:
1. United States (USFDA):
New Drug Application (NDA) Filing: Assisting in the preparation and submission of NDAs for pharmaceutical products.
2. European Union (EMA):
European Medicines Agency Submission: Guiding the submission process for marketing authorization applications in the EU.
3. Canada (Health Canada):
Drug Submission: Supporting drug submission applications to Health Canada for market approval.
4. Japan (PMDA):
Pharmaceuticals and Medical Devices Agency Filing: Facilitating regulatory filings with PMDA for product approval.
5. Australia (TGA):
Therapeutic Goods Administration Submission: Preparing and submitting applications for product registration.
6. Brazil (ANVISA):
ANVISA Registration: Assisting in the registration process with the National Health Surveillance Agency in Brazil.
7. China (NMPA):
National Medical Products Administration Submission: Navigating the regulatory landscape for product filings in China.
Non-Regulated Markets:
8. Chile:
ISP Submission: Assisting with submissions to the Chilean Public Health Institute for market authorization.
9. South Africa (SAHPRA):
South African Health Products Regulatory Authority Filing: Guiding the submission process for regulatory approval in South Africa.
10. India (CDSCO):
Central Drugs Standard Control Organization Application: Facilitating product registrations with the Indian regulatory authority.
11. Mexico (COFEPRIS):
COFEPRIS Registration: Supporting submissions to the Federal Commission for the Protection against Sanitary Risk in Mexico.
12. Russia (Minzdrav):
Ministry of Health Registration: Assisting with regulatory submissions to the Russian Ministry of Health.
13. Argentina (ANMAT):
National Administration of Drugs, Food, and Medical Technology Approval: Facilitating regulatory filings with ANMAT in Argentina.
14. Turkey (TITCK):
Turkish Medicines and Medical Devices Agency Submission: Guiding the submission process for regulatory approval in Turkey.
15. Singapore (HSA):
Health Sciences Authority Filing: Assisting with submissions to the HSA for market authorization in Singapore.
16. United Arab Emirates (MOHAP):
Ministry of Health and Prevention Approval: Supporting regulatory filings with the UAE Ministry of Health and Prevention.
Comprehensive Support:
Regulatory Strategy Development: Crafting strategic plans tailored to the regulatory requirements of each country.
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Documentation Preparation: Ensuring the completeness and accuracy of regulatory documentation for submissions.
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Communication with Regulatory Authorities: Facilitating communication and interactions with regulatory agencies to address queries and provide additional information.
Post-Approval Compliance: Assisting with post-approval compliance measures to ensure ongoing regulatory adherence.
Conclusion:
Our global market extension and regulatory filing services are designed to support pharmaceutical companies in navigating the complex regulatory landscapes of diverse countries. By providing tailored solutions for both regulated and non-regulated markets, we aim to facilitate successful product registrations and market entries worldwide.