Regulatory Affairs

At JENNA Group, our Regulatory Affairs team plays a crucial role in facilitating the successful introduction of pharmaceutical products into the Iraqi market. We offer comprehensive regulatory support to help navigate the complexities of local and international regulations, ensuring that your products meet the highest standards for safety, efficacy, and quality. Our expertise covers every stage of the product lifecycle, from initial registration and compliance assessments to post-market surveillance.

As an additional service, we provide tailored regulatory consulting that addresses the unique challenges faced by our clients in the pharmaceutical industry. Our knowledgeable team assists with the preparation of necessary documentation and submissions, ensuring timely approvals from the Iraqi Ministry of Health. We also prioritize pharmacovigilance services to monitor the ongoing safety of products once they reach the market, helping our clients maintain compliance and safeguard public health.

With our regulatory support, you can focus on your core business objectives, knowing that your products are backed by a team dedicated to ensuring compliance and enhancing market access. Let us partner with you to navigate the regulatory landscape efficiently and effectively, ensuring your products achieve their full potential in Iraq.

Comprehensive Regulatory Support

We offer a full suite of regulatory support services tailored to the unique needs of your products. From initial assessments to final approvals, our expert team ensures that every aspect of regulatory compliance is met, minimizing risks and streamlining the process for our clients.

Efficient Product Registration

Our streamlined product registration service is designed to facilitate a swift and effective submission process. We handle the preparation of all necessary documentation, ensuring accuracy and compliance with local and international guidelines, which helps reduce time to market.

Strategic Market Entry

We provide strategic insights and guidance for successfully entering new markets. Our team analyzes market conditions, competitive landscapes, and regulatory requirements, enabling clients to make informed decisions and optimize their market entry strategies.

Ongoing Compliance Management

Maintaining compliance is crucial for long-term success. We offer ongoing compliance management services that monitor and review your processes and products, ensuring that you remain aligned with evolving regulations and industry standards.

Pharmacovigilance Integration

Our pharmacovigilance integration service enhances product safety by continuously monitoring and evaluating the effects of pharmaceutical products. We assist clients in establishing robust reporting systems and protocols to ensure compliance with safety regulations, thereby protecting both patients and the company.