RA Consulting

BND BIO: 규제 전문가, 성장 가속화를 위한 파트너

UAE·중동 시장 진출을 가속하는 End‑to‑End 규제·제품개발 서비스. 복잡한 절차는 저희가 간소화하고, 귀사는 핵심 비즈니스 성장에만 집중하실 수 있도록 돕겠습니다.

보건부(MOH) 발급 공식 의료·일반 무역 라이선스 보유

제약사·정부기관·투자자·현지 유통사로 이어진 광범위 네트워크

UAE 내 한국 의료 회사 대상 의료 라이선스 보유 파트너

UAE 시장 진입, 가장 확실한 경로

BND BIO는 의료기기, 의약품, 화장품, 일반 및 화학 산업 기업의 UAE·중동 시장 진출을 돕기 위해 설립되었습니다. 보건부(MOH) 발급 공식 의료 및 일반 무역 라이선스를 보유하고 있으며, 폭넓은 비즈니스 네트워크를 기반으로 시장 진입과 확장을 체계적으로 지원합니다.

특히 UAE 내에서 한국 의료 회사를 위한 의료 라이선스를 보유한 파트너로서, 전략적인 솔루션과 비교할 수 없는 실행력을 제공해 성공적인 진입과 성장을 이끕니다.

성공적인 시장 진출 4단계 프로세스

STEP 01

초기 진단 및 컨설팅

제품·조직 현황 심층 진단
우선 시장/카테고리 스코핑
규제 리스크와 초기 비용 가늠

STEP 02

전략 및 타임라인 설계

분류·자료갭 분석 보고서
라벨/포장/광고 요건 정의
기관별 경로·최적 일정 수립

STEP 03

등록·승인 실행 및 대응

신청서·기술문서 패키징
기관 커뮤니케이션/보완 대응
현지 시험·번역·공증 연계

STEP 04

출시 및 확장 지원

통관·유통·광고 컴플라이언스
사후관리(Surveillance) 체계 구축
GCC/MENA 확장 로드맵 제공

BND BIO를 선택해야 하는 결정적인 이유

End-to-End 원스톱 실행력

전략 수립부터 등록, 출시 후 사후관리까지 단일 창구에서 신속하게 처리하여 효율성을 극대화합니다.

실무형 현지화 경쟁력

라벨·포장·광고·유통 규정에 맞춘 실질적인 현지화로 불필요한 시행착오와 시간 낭비를 최소화합니다.

데이터 기반 규제 인텔리전스

기관별 심사 포인트 및 보완 사례를 데이터로 축적하여 질의 대응 속도와 성공률을 높입니다.

지속적인 성장의 동반자

단순 승인을 넘어 변경관리·재등록·GCC 확장 전략까지 아우르는 지속 가능한 파트너십을 약속합니다.

BND BIO: Regulatory Experts, Partners for Accelerated Growth

End-to-End Regulatory and Product Development Services accelerating entry into the UAE and Middle East markets. We simplify complex procedures, allowing your company to focus solely on core business growth.

Holds **Official Medical and General Trade License** issued by the Ministry of Health (MOH)

**Extensive Network** spanning pharmaceutical companies, government bodies, investors, and local distributors

Partner holding a medical license specifically for **Korean Healthcare Companies** within the UAE

ABOUT US

UAE Market Entry, The Most Reliable Path

BND BIO was established to assist companies in the Medical Device, Pharmaceutical, Cosmetic, General, and Chemical industries in their **UAE and Middle East market entry**. We hold an **Official Medical and General Trade License** issued by the Ministry of Health (MOH) and provide systematic support for market penetration and expansion based on an extensive business network.

As a licensed partner specifically for **Korean medical companies** within the UAE, we provide strategic solutions and unparalleled execution power, driving successful entry and growth.

Official License: Holds MOH Medical & General Trade License
Extensive Network: Full-stack coverage across Pharma, Gov't, Investment, and Distribution
Key Markets: Maximized access to UAE and GCC markets
Differentiating Strength: Providing Action-Oriented One-Stop Solutions

CORE VALUES

Core Values BND BIO Stands For Commitment

All our services are based on the following four core values, which are our commitment to our clients' successful establishment in the Middle East market.

Regulatory Simplification

Structures and automates complex procedures, allowing you to focus on core business.

Expertise and Accuracy

Provides accurate and reliable solutions based on the latest regulatory trends and pre-review experience.

Trust-Based Partnership

Engages in transparent communication and results-driven collaboration based on long-term partnership.

Market Growth Support

Ensures execution capability by co-designing the entire journey from UAE/Gulf market entry to expansion.

OUR EXPERTISE

One-Stop Regulatory Solution Categories

We provide full product development and regulatory services through a **single window**. We design the optimal registration path and timeline by combining category-specific requirements.

Supported Agencies: DM · MOIET · MOHAP · EDE · DOH · DHA

Pharmaceuticals (Conventional Products)

Registration and approval strategies for Prescription/OTC drugs, Technical Document (CTD/eCTD) packaging

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

Medical Devices

Classification, Conformity Assessment, Clinical/Non-clinical data packages, Post-Market Surveillance (PMS) system setup

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

Quasi-Drugs (Health & Hygiene)

Item-specific requirement fulfillment (e.g., disinfectants, sanitary goods), Quality System and GMP linkage support

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

Cosmetics

CPNP-like documentation, Ingredient review, Labeling localization, PIF and CPSR preparation support

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

Aesthetic Devices

Aesthetic/Wellness device conformity and advertising review, Proxy services for related agency certifications

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

Food & Health Supplements

Ingredient, nutrition, and health claim review, Customs clearance support, Local FDA standard compliance verification

Requirement analysis and optimal dossier packaging
Review of Labeling, Advertising, and Customs compliance
Rapid response to agency inquiries and deficiencies

PROCESS

Successful Market Entry 4-Step Process

STEP 01

Initial Diagnosis & Consulting

In-depth diagnosis of product and organizational status
Scoping of priority markets/categories
Assessment of regulatory risks and initial costs

STEP 02

Strategy & Timeline Design

Classification and Gap Analysis Report
Definition of Labeling/Packaging/Advertising requirements
Establishing agency-specific paths and optimal timelines

STEP 03

Registration, Approval Execution & Response

Application and technical dossier packaging
Agency communication and deficiency response
Local testing, translation, and notarization coordination

STEP 04

Launch & Expansion Support

Customs, distribution, and advertising compliance
Establishing Post-Market Surveillance (PMS) system
Providing GCC/MENA expansion roadmap

WHY CHOOSE US

Why Choose BND BIO: The Decisive Reasons

End-to-End One-Stop Execution

From strategy development to registration and post-launch management, all processes are handled swiftly through a single window, maximizing efficiency.

Practical Localization Expertise

Tangible localization tailored to labeling, packaging, advertising, and distribution regulations minimizes unnecessary trial-and-error and time waste.

Data-Driven Regulatory Intelligence

Agency-specific review points and remediation cases are accumulated as data, enhancing response speed and success rates for inquiries.

Partner for Continuous Growth

Beyond simple approvals, we promise a sustainable partnership covering change management, re-registration, and GCC expansion strategies.

Medytox

BR Pharm

Healing Solution

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Derma Class