Simplifying Regulatory
Regulatory Consulting Services & Solutions
Leverage our local Saudi full time experts in Regulatory Affairs and SFDA Consultations. Providing end-to-end regulatory services designed to help international companies enter and grow in Saudi Arabia and the wider GCC region. Our in-house experts—many with SFDA experience—handle everything from strategic planning and submissions to lifecycle management and post-marketing compliance.
Regulatory Strategy
Local Representation
Marketing Authorisation
Lifecycle Management
Compliance Oversight
Submission Support
- In-country experts with SFDA experience
End-to-end regulatory project execution
Seamless support across MENA markets
Flexible models for every business size
Local presence. Global standards
Regulatory Solutions
Reliable local regulatory representation for companies without a physical presence in Saudi Arabia, ensuring SFDA compliance from day one.
We offer a fully outsourced regulatory affairs solution for international pharmaceutical and biotech companies. Our Riyadh-based office is staffed with experienced regulatory pharmacists—no remote workers—who manage all regulatory activities with the Saudi Food and Drug Authority (SFDA). We handle drug and biotechnology product registration, respond to SFDA inquiries, manage post-approval changes, and ensure full compliance with local regulations. Our team already supports famous global companies, acting as their in-country regulatory partner. With deep knowledge of SFDA systems and processes, we help clients reduce risk, accelerate approvals, and maintain compliance. Our office-based structure allows for faster communication and reliable execution, giving you the benefits of a local team without the need to establish one. PharmaKnowl’s Managed Regulatory Function is your trusted regulatory presence in Saudi Arabia.
This solution is tailored for international companies that do not yet have an appointed distributor in Saudi Arabia. We offer a practical solution: acting as your Interim Local Agent to fast-track SFDA submissions. Since a local agent is required to submit products to the SFDA, many companies face delays while searching for and negotiating with commercial distributors. Our service removes that bottleneck. As an independent regulatory service provider with no commercial interests, PharmaKnowl can act as your temporary local agent, allowing you to start the registration process immediately. This approach gives you a head start: you can move forward with SFDA submissions while continuing your distributor search in parallel. Our well-established solution helps you accelerate market access and maintain control of your product strategy from day one.
Explore our pioneer solution for pharmaceutical or biotech multinational companies to comply with the regulatory obligation to license a local scientific office (SO) in Saudi Arabia On behalf of our partners, we host their local affiliate offices, license them by SFDA, and manage their operations. This includes appointing a licensed pharmacist as a managed full-time employee (FTE). Leverage our SO expert supervision to maintain a compliant quality system, seamless operations, professional communication, and coverage of all post-marketing activities, with a strong relationship with the authorities. Our Managed SO service is ideal for achieving compliance without the overhead of establishing a local entity.
We serve as your single point of contact for all regulatory activities across GCC countries, acting as a centralized regulatory hub that simplifies and streamlines your regional operations. Instead of managing multiple distributors and fragmented regulatory inputs, you’ll work with one dedicated regulatory partner. We coordinate submissions, track regulatory changes, and ensure consistency in messaging and compliance across markets like Saudi Arabia, UAE, Oman, Kuwait, and beyond. Our deep understanding of the region’s regulatory environment allows for accelerated market access, clarity, speed, and confidence in every market—through one expert team.
Independent AR for MedTech companies without conflict.
In Saudi Arabia, MedTech companies must appoint a local Authorised Representative (AR) to register and maintain medical device approvals with the SFDA. At PharmaKnowl, we provide independent Authorised Representative (AR) services without commission on shipments and separate from any commercial distributor, giving you greater flexibility, control, and long-term value. By appointing us as your AR, you gain access to advanced regulatory and post-marketing support while keeping full control over your product licenses. Unlike using a commercial distributor as your AR, our independent model allows you to register multiple brand names for different distributors, ship products to various importers, and switch distributors without impacting your regulatory status. We ensure stable operations, high responsiveness, and reliable data confidentiality. You also benefit from unbiased regulatory advice, up-to-date market insights, and timely communication with SFDA.
From Application to Launch – Every Step Covered
Regulatory Projects
We lead regulatory-driven projects to support registration, product transfers, and localization initiatives.
Securing marketing authorisation is at the core of what we do in PharmaKnowl. Our clients rely on our team of former SFDA experts, proven gap analysis methods, and streamlined regulatory operations to get their products approved faster and with fewer obstacles. For every submission, we assign an experienced project manager and a deputy project manager to work closely with your global team. Together, we gather requirements, perform detailed gap analysis, and tackle prerequisites in parallel to keep timelines tight and submissions moving forward. During authority review, our team efficiently manages Requests for Information (RFIs), simplifying the response process for stakeholders such as API manufacturers, finished product manufacturers, and the MAH. We interpret CMC, clinical, and market-specific requirements and can help develop any missing documentation. We specialize in registering a wide range of products, including ATMPs, biologics, biosimilars, new chemical entities, generics, and medical devices.
PharmaKnowl is your trusted partner for successful registrations with SFDA, GHC, and across GCC.
Transferring a Marketing Authorisation (MA) in Saudi Arabia is a critical regulatory process that goes far beyond submission requirements. It directly impacts the supply chain, requiring careful coordination to avoid disruptions due to cut-off obligations, ongoing product availability, and compliance risks. At PharmaKnowl, we manage the full scope of Marketing Authorisation Transfer (MAT) with a structured, hands-on approach. We coordinate with all stakeholders, including the former MAH, manufacturers, importers, and suppliers, to ensure a smooth and compliant transition. Our regulatory team handles technical and non-technical variations often accompanying MAT, including updates to labeling, packaging, site changes, and other post-approval requirements that must be processed alongside the transfer. With deep knowledge of SFDA expectations and clear project oversight, we help clients complete MAT efficiently while safeguarding their supply chain and regulatory standing. PharmaKnowl is your trusted partner for risk-managed, end-to-end Marketing Authorisation Transfer in Saudi Arabia and other markets.
We support international companies establishing local manufacturing operations in Saudi Arabia through efficient tech transfer and regulatory guidance. As the Kingdom pushes for increased local production under Vision 2030, entering the local manufacturing space is both a strategic opportunity and a regulatory challenge. We guide you through the process, from feasibility and partner identification to regulatory approvals, tech transfer planning, and SFDA licensing. Our team ensures compliance with SFDA requirements at every step, including GMP inspections, site variation filings, and local testing obligations. We coordinate with your global manufacturing sites, local CMOs, and relevant SFDA departments to streamline documentation, timelines, and execution. Whether you’re transferring full production or packaging activities, we help you navigate the technical and regulatory complexities. We understand the process, speak the regulatory language, and keep your tech transfer on track.
We support pharmaceutical, biotech, and MedTech companies with out-licensing and in-licensing activities in Saudi Arabia and the wider MENA region. For out-licensing, we help companies identify and connect with qualified local partners or distributors seeking innovative or in-demand products. We provide regulatory insights, market intelligence, and strategic support to position your product competitively and ensure it meets SFDA requirements for licensing and commercialization. For in-licensing, we work with local companies and investors looking to expand their portfolios with international products. We assist in screening global opportunities, conducting regulatory due diligence, and assessing the feasibility of registration in Saudi Arabia. Our deep understanding of the commercial and regulatory landscape allows us to match the right products with the right partners efficiently and strategically.
Maintain compliance. Minimize disruption.
Regulatory Operations
Managing all your post-approval regulatory activities to keep your products compliant and supply uninterrupted.
End-to-end handling of variations, renewals, and updates.
At PharmaKnowl, we handle the full spectrum of Life Cycle Management (LCM) to keep your products compliant and consistently available in the Saudi market. We handle all post-approval regulatory work, including variations, renewals, labeling changes, safety updates, and packaging modifications. We treat every change as a standalone project, bundling the most possible together in one submission. All in alignment with your company plans and SFDA expectations. Whether you’re managing one product or an entire portfolio, we provide proactive planning, clear regulatory guidance, and timely submissions to avoid delays and minimize risk. Keeping your commercial goals in focus, we ensure your licenses stay valid, your product supply remains uninterrupted, and your long-term success in Saudi Arabia and the MENA region is fully supported.
We offer professional eCTD publishing services to ensure your regulatory submissions meet SFDA and Gulf Health Council (GHC) standards. Our experienced team handles the end-to-end publishing process, including formatting, validation, and submission through official portals. We work with original dossiers, variations, renewals, and responses to inquiries, ensuring they are fully compliant with technical requirements and regulatory expectations. With in-house tools and expertise, we reduce errors, prevent delays, and support smooth regulatory reviews.
Localized, accurate labelling aligned with regulatory and PV requirements.
We provide full labelling compliance support, ensuring your packaging materials meet market-specific requirements in Saudi Arabia and the region. Our team is well-versed in local regulatory and safety labelling standards and accurate medical translation. We assist in developing and reviewing artwork, leaflets, SPCs, and IFUs to ensure consistency and compliance. We also help unify packaging across multiple markets, considering supply chain complexities to streamline operations. For rare disease products, we support SFDA waiver requests to use general international packs, which reduce delays and avoid unnecessary customisation. We ensure your labelling is compliant, efficient, and market-ready for initial registration or post-approval updates.
Clarity before commitment
Regulatory Consulting
We provide expert regulatory insight and strategic advice to guide your decisions with confidence.
Identify risks and readiness with our multi-level assessment model.
Comprehensive due diligence and gap analysis are critical to assessing regulatory readiness and avoiding costly investment delays or missteps. Whether you are preparing for product registration, pursuing a licensing agreement, or planning a new market entry, we help you see the entire regulatory landscape, identifying risks, gaps, and opportunities before you take the next step. In PharmaKnowl, we developed a multi-level deep analysis that generates strategic, decision-ready reports tailored to senior management. Our evaluations cover:
Product File Gap Analysis:
- Critical CMC and clinical data requirements
- Time-intensive components
- High-cost, long-lead-time obligations
- Advanced compliance needs based on market laws
- Minor but necessary market-specific updates
Due Diligence on Involved Entities:
- Finished product manufacturers
- API suppliers
- MedTech subcontractors
- MAH and legal manufacturer status and relationship structures
With PharmaKnowl, we help you move forward with clarity, control, and confidence.
At PharmaKnowl, we specialize in crafting tailored regulatory strategies for companies aiming to enter the Saudi Arabian market. Recognizing the complexities of the Saudi Food and Drug Authority (SFDA) regulations, our approach integrates:
- Company Objectives: Aligning regulatory plans with your business goals.
- Product Specifications: Ensuring strategies are product-specific and compliant.
- Applicable Regulations: Navigating the latest SFDA guidelines effectively.
- Regulatory Intelligence: Leveraging insights to anticipate and mitigate potential challenges.
- Stakeholder Input: Collaborating with all relevant parties for a cohesive strategy.
Our comprehensive analysis encompasses compliance risks, dossier evaluations, and market-specific requirements, facilitating smooth market access and optimized launch timelines. Partner with us to navigate the Saudi regulatory landscape confidently.
Expert preparation and representation in SFDA meetings.
We proudly represent companies in meetings with the SFDA through our regulatory experts, ensuring your interests are clearly and professionally communicated during face-to-face or virtual meetings with SFDA departments. We support clients in preparing for scientific advice meetings, pre-submission discussions, and technical clarifications, helping them ask the right questions and present the correct data. Our role includes drafting meeting requests, preparing briefing documents, guiding discussion points, and attending on their behalf when needed. We help you avoid missteps, gain clarity on requirements, and accelerate approvals through effective regulatory engagement.
Handle rejections, pricing issues, or variations with a strong appeal strategy.
We support you in preparing and submitting formal appeals to the SFDA when faced with regulatory rejections, objections, or unfavorable decisions. Our team assesses the authority’s response, identifies grounds for appeal, and builds a clear, evidence-based case aligned with SFDA regulations and expectations. We draft and structure the appeal documents, support any required scientific justifications, and represent you in follow-up discussions. With our deep understanding of SFDA processes and decision-making criteria, we help maximize your chances of a successful outcome. Whether the issue involves registration or variation rejection or low drug prices, PharmaKnowl is your trusted partner for navigating the SFDA appeals process with confidence and precision.
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