Regulatory Affairs Services Provider in Israel
Israel is a highly regulated and innovation-driven life sciences market, with strong alignment to international regulatory frameworks including ICH, FDA, and EU standards. However, successful product registration and ongoing compliance in Israel require a clear understanding of Ministry of Health (MOH) procedures, local documentation requirements, and market-specific regulatory expectations.
At DDReg, we provide specialized Regulatory Affairs Services in Israel, supporting global and regional pharmaceutical, biotechnology, and medical device companies with product registration, market entry, and lifecycle regulatory compliance. As a trusted Regulatory Affairs Consultant in Israel, DDReg delivers regulator-ready submissions and practical regulatory execution aligned with Israeli authority requirements.
Understanding the Regulatory Affairs Process in Israel
Regulatory oversight in Israel is governed by the Israeli Ministry of Health (MOH), primarily through its Pharmaceutical Division and Medical Devices Division. The MOH is responsible for:
- Approval and registration of pharmaceutical products and biologics
- Regulation of clinical trials and investigational medicinal products
- Medical device registration and conformity assessment
- Oversight of GMP, GCP, and GDP compliance
- Post-market surveillance, safety reporting, and enforcement
TAs an experienced Israel Regulatory Consultant, DDReg supports clients across the full regulatory affairs process in Israel, ensuring submissions comply with current MOH guidance and established review practices.
Our Regulatory Affairs Expertise in Israel
DDReg offers end-to-end regulatory consulting services in Israel, supporting both multinational companies and emerging life sciences organizations. Our approach combines local regulatory intelligence with global regulatory best practices to facilitate efficient approvals and sustainable market access. We work closely with Israeli regulatory expectations to reduce approval timelines, manage authority interactions, and support long-term regulatory compliance.
Our Regulatory Affairs Consulting Services in Israel
- Regulatory strategy and Israel market entry pathway assessment
- Product classification and regulatory compliance mapping
- Pre-submission planning and regulatory readiness assessments
- Preparation, publishing, and submission of regulatory dossiers
- Pharmaceutical regulatory affairs support in Israel
- Drug regulatory consulting for new, generic, and established products
- Regulatory Services for Medical Devices in Israel across applicable risk classes
- Technical documentation and conformity assessment support
- Labeling, packaging, and local language compliance review
- Authorized local representative and in-country regulatory support
- Regulatory liaison and communication with the Israeli MOH
- Gap analysis and regulatory remediation planning
- Lifecycle management, including renewals, variations, and post-approval changes
- Regulatory query handling and deficiency response management
- Post-market regulatory compliance and change control
- Ongoing local regulatory intelligence and policy monitoring
As a dedicated Israel Regulatory Consulting Firm, DDReg ensures consistent, authority-aligned regulatory execution throughout the product lifecycle.
Why Choose DDReg as Your Regulatory Affairs Consultant in Israel?
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MOH-Focused Regulatory Expertise
Our consultants possess hands-on knowledge of Israeli MOH procedures, review timelines, and documentation standards. -
Local Execution with Global Regulatory Alignment
We support Israel-specific submissions while maintaining alignment with ICH and internationally recognized regulatory frameworks. -
Strategic Partner for Market Access
DDReg is more than a regulatory service provider. We support long-term compliance, lifecycle management, and regulatory risk mitigation in Israel.
Industries We Support in Israel
- Pharmaceutical and Generic Drug Manufacturers
- Biotechnology and Life Sciences Companies
- Medical Device and Diagnostics Manufacturers
- Combination Products and Innovative Therapies
- Companies entering or expanding within the Israeli market
Our Regulatory Affairs Consulting Services in Israel portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
