Regulatory Assessment and Gap Analysis

Regulatory Assessment and Gap Analysis

Streamlining Compliance for Product Success

At Saba Regulatory, we offer comprehensive regulatory assessment and gap analysis services to support manufacturers in navigating the complex regulatory landscape. Our aim is to help our clients understand and address critical points throughout the product lifecycle, ensuring compliance and expediting the approval process.

During the product development process, regulatory assessment plays a crucial role in ensuring a smooth regulatory journey. It involves a thorough evaluation of the product’s compliance with regulatory requirements before submission, during the review and approval phase, and even after approval for the international market.

Our team of regulatory experts works closely with manufacturers to identify potential gaps and address them proactively. By conducting a comprehensive gap analysis, we help manufacturers understand any shortcomings in their regulatory strategies, labeling, and overall lifecycle management.

Our services are designed to support organizations in every stage of their product development journey. From providing necessary information and pragmatic solutions for newly developed products to assisting with market authorization, we are here to streamline the regulatory process and help enhance the commercial worth of your products.

As part of our regulatory affairs services, we handle submissions to the health authority, ensuring that all necessary approvals and postings are obtained. We also provide support in areas such as CMC (Chemistry, Manufacturing, and Controls) and lifecycle maintenance, enabling organizations to maintain regulatory compliance and stay ahead in the market.

At Saba Regulatory, our global regulatory affairs expertise spans across various industries, including Life Sciences, Consumer Pharma, and Bio-Med. We understand the intricate and varying regulatory standards and can help you successfully introduce your products into new markets while maximizing their value.

In Iraq, we are well-versed in the regulatory landscape and have extensive knowledge of the local requirements and procedures. We work closely with the relevant authorities to ensure that your products meet all regulatory standards and gain the necessary approvals for market entry.

Some key areas covered in our regulatory assessment and gap analysis services include:

New Registrations

We assess the regulatory compliance of new product registrations, ensuring that all necessary documentation and requirements are met.


We help manufacturers maintain the registration status of their products by guiding them through the renewal process. Our experts ensure that all renewal requirements are fulfilled in a timely manner.


We evaluate product labeling to ensure compliance with local and international regulations. We review labels for accuracy, clarity, and adherence to labeling guidelines.

Lifecycle Management

We assist manufacturers in maintaining the registration status of their products throughout the lifecycle. This includes managing post-approval changes, updating documentation as needed, and ensuring ongoing compliance.

Our approach involves a combination of comprehensive regulatory knowledge, in-depth analysis, and strategic guidance. We provide manufacturers with actionable insights and recommendations to address any gaps and enhance their regulatory compliance. By proactively addressing potential issues, we help minimize delays and increase the chances of successful regulatory approvals.

Partner with Saba Regulatory for efficient regulatory assessment and gap analysis services that ensure compliance and pave the way for product success. Our dedicated team is committed to guiding you through the complexities of regulatory requirements and helping you achieve your regulatory goals with confidence.