Regulatory Affairs
At Maxeome, we specialize in regulatory strategy and submission support for dermatology and aesthetic medicine products, including injectables, exosomes, and medical devices. We tailor regulatory strategies to meet global and local requirements, including Saudi Food and Drug Authority (SFDA), Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations. Our regulatory affairs services help ensure that your innovations meet regional and international standards and reach the market smoothly.
Saudi Food and Drug Authority
We guide your product through the SFDA process with precision and speed. From classification and registration to dossier submission and authority responses.
Institutional Review Board
We manage all aspects of IRB submissions for your clinical study, including documentation, formatting, and follow-up. Our team ensures ethical compliance with ICH-GCP, fast approvals, and alignment with both local and international standards.
Investigational New Drug (IND)
We support regulatory submissions for investigational products ahead of clinical trials in Saudi Arabia and beyond. Services include scientific strategy, pre-submission preparation, and full application support.
Regulatory Strategy Development
We design clear, risk-informed regulatory plans tailored to your product and market. Whether you're launching in Saudi Arabia or globally, we help you determine classification, data requirements, market entry pathway, and submission timelines.
What We Do
Regulatory Strategy and Roadmapping
We assess your product’s classification and regulatory pathway across key markets, including SFDA, FDA, EMA, and GCC authorities. Whether it’s a Class I device or a biologic, we develop a step-by-step plan that fits your goals and timelines.
Dossier Preparation and Submission
We prepare and review Common Technical Documents (CTDs) and other regulatory submissions. From Module 1 to Module 5, we ensure all data is well-organized, scientifically sound, and regulator-ready.
Regulatory Strategy and Roadmapping
Get your product labels, inserts, and promotional content aligned with regulatory expectations, especially critical in aesthetic medicine, where wording must be both compliant and compelling.
Regulatory Gap Analysis
We analyze your data against the requirements of your target market and identify any missing elements. This minimizes delays and maximizes submission success.
Post-Market Regulatory Support
We support variations, renewals, pharmacovigilance compliance, and periodic safety updates (PSURs/PBRERs). Our team helps maintain your product’s regulatory standing even after launch.
Case Study
Client
Pharmaceutical company launching and CE-marked injectable for an aesthetic indication in Saudi Arabia
Challenge
The client needed to register their product with the Saudi Food and Drug Authority (SFDA) but was unsure how it would be best classified locally: medical device, drug, or cosmetic. They also needed to adapt their European dossier to meet SFDA requirements and managing the submission process.
Maxeome's Approach
We assessed the product and determined the optimal regulatory pathway. After confirming the appropriate classification through consultation with SFDA, we performed a detailed gap analysis on the client's EU dossier and identified areas that required modification for local compliance. We managed the full application process on behalf of the client. Throughout the submission, we served as the regulatory liaison, providing timely responses to authority queries and maintaining alignment with the client’s launch objectives.
Outcome
The SFDA registration was completed without major queries or delays. The product was successfully classified and cleared, enabling the client to proceed with a nationwide launch across aesthetic clinics in Saudi Arabia.
How is Regulatory Affairs different with Maxeome?
Dermatology & Aesthetic Focus
We specialize in skin-related products, including injectables, medical devices, and novel interventions like exosomes. That means faster onboarding, fewer missteps, and strategies tailored to your field.
Local & Global Regulatory Expertise
We know the regulatory expectations of the SFDA and GCC authorities. Whether you're entering the Saudi market or expanding internationally, we guide your product through the right pathway right from the start.
Integrated with Clinical & Scientific Strategy
We align your regulatory plan with your data generation strategy. That means your submissions are not only compliant but credible and evidence-based.
Dynamic, Expert-Led
Our compact, senior-led team offers fast turnarounds, direct access to specialists, and a hands-on approach that is unmatched. We are built to be your strategic partner, not just a service provider.