In the global pharmaceutical market, Setting up a scientific and efficient global registration strategy is crucial to the success of development, approval and marketing of the drugs. Given its profound international regulatory experience and practical solution in multinational registration, Brilliantmed provides pharmaceutical companies with full life cycle registration strategy support, facilitating efficient and compliant products track to the global market and sustaining long-term competitive advantages.

We provide customized global registration strategy services around different stages of the pharmaceutical life cycle, including:

1. Early R&D stage

In the early stages of drug development, it is crucial to develop a correct global registration strategy and we provide:

· Global market access analysis: evaluate the regulatory requirements of target markets (such as the US FDA, European EMA, China NMPA, Singapore HSA, etc.) and design appropriate registration strategies.

· Non-clinical research compliance support: Guide companies to comply with GLP (good laboratory specifications) requirements and ensure that non-clinical research data complies with international standards.

· Preclinical communication and advice: Assist companies and regulatory agencies (such as FDA Pre-IND, EMA Scientific Advice, NMPA CDE communication meeting) in early communication and optimize registration strategies.

2. Clinical trial stage

The design and registration strategies of clinical trials directly affect the progress of drug marketing, and we provide:

· Clinical trial application (CTA/IND application): Supports the preparation, submission and full life cycle management of new drug clinical trial application (IND) and clinical trial application (CTA).

· Global multi-center clinical trial registration coordination: Ensure clinical trials comply with local regulations and improve the global applicability of data.

· Communication support of regulatory agencies: Provide regulatory review questions response strategies to ensure the smooth progress of clinical development.

· Support for rare diseases and accelerated approval paths: Guide enterprises to apply for special channels such as Orphan Drug, Breakthrough Therapy, Fast Track, etc. to improve clinical development efficiency.

3. New drug registration stage

A successful new drug market registration strategy determines whether drugs can enter the market quickly. We provide:

· Marketing Authorization Application (MAA/NDA/BLA): Document preparation, review and submission of new drug applications (NDA/BLA) and marketing authorization applications (MAA).

· CTD/eCTD document writing and compliance inspection: Ensure that the registration and declaration documents comply with the ICH CTD structure and national regulations and improve the approval success rate.

· Multi-country registration coordination and approval tracking: Ensure that drug registration applications are submitted simultaneously in multiple countries and regions, and improve global market coverage.

· Priority review and special approval paths: Support policy applications such as Priority Review and Conditional Approval to accelerate product launch.

4. Post-Marketing & Lifecycle Management

After the drug is successfully launched, it still requires continuous compliance management and registration and maintenance. We provide:

· Variation & Lifecycle Management: Supports regulatory affairs such as CMC changes, new indications, dosage form optimization, production changes, etc.

· Post-market safety management (Pharmacovigilance): Ensure compliance with pharmacovigilance (PV) regulations of various countries and support post-market adverse reactions (ADR) monitoring and reporting.

· Generic/biosimilar market access support: Provide registration strategies and market access support for generic drugs (ANDA) and biosimilar to ensure product competitive advantages.