Associate Partner
Comprehensive solutions for Medical Devices, Small Molecule Drugs, and Biologicals – accelerating approvals in India, SFDA, GCC, and beyond with precision and compliance.
Get in Touch
Saudi Arabia (SFDA)
MedwisdomLifescienceprovides specialized regulatory affairs and
market access support for biological and biotechnology products
seeking approval in Saudi Arabia. We assist global and regional
companies in navigating the complex regulatory environment
governed by the Saudi Food and Drug Authority (SFDA) with clarity,
confidence, and compliance.
Biological and biotech products are inherently complex due to their sensitive nature, advanced manufacturing processes, and strict quality controls. SFDA applies a high level of scientific and regulatory scrutiny to these products, making expert regulatory planning essential. MedwisdomLifescienceacts as a trusted partner, ensuring that every regulatory requirement is addressed accurately and strategically.
Contact Us
Our regulatory expertise covers a wide range of biological and biotech products, including:
Each product category is evaluated individually to determine the most appropriate SFDA registration pathway.
We follow a structured and client-centric regulatory approach designed to simplify complex biological registrations:
We begin with a detailed review of the product, manufacturing process, and global approval status to define the most suitable SFDA submission route.
Our team supports the preparation, review, and gap analysis of CTD dossiers, with particular focus on quality (CMC), non-clinical, and clinical data, which are critical for biologicals.
We manage online submissions through SFDA systems and handle all regulatory communication, including scientific queries and clarification requests.
Biological products often require enhanced GMP evidence, manufacturing site information, and cold chain documentation. We help ensure readiness for inspections and compliance reviews.
Support continues beyond approval, including variations, renewals, and ongoing regulatory compliance.
Our expertise ensures that these requirements are addressed proactively, reducing approval delays.
We translate complex scientific data into clear, regulator-ready submissions while keeping our clients informed at every step.
· Focused Expertise in Biologics & Biotech Regulations
· Strong Understanding of SFDA Scientific Review Expectations
· Risk-based Regulatory Strategy to Reduce Delays
· Clear Communication and Realistic Timelines
· End-to-End Regulatory Ownership
Biological & Biotech Products
Timelines vary based on product complexity, clinical data, and SFDA
review scope. Typical estimates include:
Note: Timelines may extend depending on inspection
requirements or additional data requests.
⏱️ 3–4 months
⏱️ 12–18 months
⏱️ Upon successful review and compliance
Biological and biotech products demand precision, scientific depth,
and regulatory foresight. Medwisdom Lifescience enables companies to
approach the Saudi market with a well-defined regulatory roadmap and
confidence in compliance.
Medwisdom Lifescience – Advancing biological innovation through
regulatory excellence in Saudi Arabia.
· Saudi Food and Drug Authority (SFDA)
https://www.sfda.gov.sa/en
· SFDA – Drug Sector & Biological Product Guidelines
https://www.sfda.gov.sa/en/drugs
· SFDA Regulatory Framework & Circulars
https://www.sfda.gov.sa/en/regulations
Specialized regulatory affairs services for biologics, biosimilars, and biotechnology-derived products across pre-registration, registration, and post-approval phases.