Leverage our local 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 former SFDA experts and regulatory affairs project managers provide you with strategic guidance with hands-on execution of your submissions in the pre-marketing and post-marketing phases.
Regulatory Strategy
Local Representation
Marketing Authorization
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
Outsource your RA operations to our Riyadh-based team.
We offer fully managed outsourced regulatory affairs solutions for international pharmaceutical and biotech companies. Our internal operations are well established, with a long track record of success with leading global companies.
We are a Riyadh-based team of full-time, experienced regulatory pharmacists 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 supports 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 internal communication, reliable execution, and physical access to SFDA, 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.
Submit your products to SFDA while searching for a distributor.
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 in Saudi Arabia, to fast-track your SFDA submissions.
Since a local agent is required to submit products to the SFDA, many companies face delays in 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, allowing you to 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.
Licensed local affiliate office solution for SO compliance.
Explore our pioneer solution for pharmaceutical & biotech 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, obtain their licenses from the 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.
Single point of contact for all GCC regulatory activities.
We serve as your single point of contact for all regulatory activities across GCC countries, acting as a centralised 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 consistent messaging and compliance across markets such as Saudi Arabia, the UAE, Oman, Kuwait, and beyond.
Our deep understanding of the region’s regulatory environment enables accelerated market access, clarity, speed, and confidence in every market through a single expert team.
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 AR services without any commissions on your shipments to your distributors, 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 complete control over your product licenses.
Unlike using a distributor as your AR, our independent model lets you register multiple brand names with different distributors, ship products to various importers, and switch distributors without affecting 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
Regulatory Projects
Compliant SFDA Submissions Trusted by Global Industry Leaders
Securing marketing authorisations is at the core of what we do in PharmaKnowl, covering a wide range of products, including ATMPs, biologics, biosimilars, and drug registration. Also, we support medical device registration through a dedicated MedTech department.
Our partners rely on our team, led by former SFDA experts, to deliver accurate gap analyses and streamlined regulatory operations, enabling their products to be 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 to gather requirements and address prerequisites in parallel, keeping timelines tight and submissions moving forward.
During authority review, we efficiently manage requests for information (RFIs), simplifying responses for stakeholders, including API manufacturers, finished product manufacturers, and the MAH.
We interpret CMC, clinical, and market-specific requirements and can help develop any missing documentation.
PharmaKnowl is your trusted partner for successful product registrations with SFDA, GHC, and across GCC countries.
Seamless, risk-managed MA transfers.
Transferring a Marketing Authorisation (MA) in Saudi Arabia is a critical regulatory process that extends well beyond mere 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 that often accompany MAT, including labeling and packaging updates, 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.
Regulatory support for local production and site transfer.
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.
Identify, evaluate, and register licensed products.
We support pharmaceutical, biotech, and MedTech companies with their 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. We assist in screening global opportunities and assessing the feasibility of registration in Saudi Arabia.
Our deep understanding of the commercial and regulatory landscape enables us to efficiently and strategically match the right products with the right partners.
Maintain compliance.
Regulatory Operations
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, labelling changes, safety updates, and packaging modifications.
We treat every change as a standalone project, bundling as many as possible into a single 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.
Professional eCTD compilation, validation, and submission.
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 our 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 the Saudi market-specific requirements.
Our team is well-versed in local regulatory and safety labelling standards, as well as 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, thereby reducing delays and avoiding unnecessary customization.
We ensure your labelling is compliant, efficient, and market-ready for initial registration or post-approval updates.
Clarity before commitment
Regulatory Consulting
Build product-specific strategies aligned with SFDA expectations.
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: Collaborate with all relevant parties to develop 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 confidently navigate the Saudi regulatory landscape.
Identify risks and readiness with our multi-level assessment model.
Comprehensive due diligence and gap analysis are critical to a strong regulatory strategy. It is a must before signing any new deal to assess the compliance of assets and companies, in addition to its importance in day-to-day regulatory projects. These processes ultimately help avoid 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 Entities:
- Finished product manufacturers
- API suppliers
- Subcontractors
- MAH and the legal manufacturer
With PharmaKnowl, we help you move forward with clarity, control, and confidence.
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 SFDA appeals 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 a submission rejection or low drug prices, PharmaKnowl is your trusted partner for navigating the SFDA appeals process with confidence and precision.
Move Forward With a Partner Trusted by Global Life-Science Leaders
Schedule a call or request a tailored proposal from our team.