Biotech – Pharma – MedTech

Strategic SFDA Regulatory Consulting

Regulatory, Clinical, & Pharmacovigilance Consulting Services, led by seasoned SFDA Consultants who design, steer, and deliver regulatory success in Saudi Arabia

0+
Years of SFDA Experience
0k
Regulatory Projects
0+
Global Clients

Trusted by Industry Leaders

Meet Us at Industry Events

Connecting with Partners & Regulators Worldwide

PharmaKnowl at the Global Health Exhibition 2025

Exhibiting at the World Drug Safety Congress, Amesterdam 2025

We are exhibiting in the 24th ISoP Annual Meeting, in Cairo

Expertise – Trust – Excellence

Our Strengths, Your Regulatory Advantage

Combining regulatory expertise, industry versatility, and trusted local presence, we deliver high-impact SFDA regulatory solutions. Our qualified team, cross-sector background, and up-to-date knowledge empower your business to meet compliance requirements with speed and confidence.

Authority-Industry

Backed by SFDA and industry experience, we support strategic planning, regulatory decision-making, and project execution.

Knowledge

Well-versed in evolving regulations and market shifts, delivering sound guidance and actionable regulatory intelligence.

Credentialed

Licensed pharmacists and biotechnologists with hands-on experience across diverse product categories and life science sectors.

Proven

Trusted by leading pharmaceutical, biotech, and MeTech companies as a reliable local partner and authorised representative.

Services & Solutions

Explore Our Solutions & Services for Life Science Industries

Regulatory Affairs

Comprehensive support in navigating Saudi regulatory requirements, focusing on strategy development, submissions, local teams, and efficient life cycle management.

Pharmacovigilance

Saudi QPPV & Pharmacovigilance services ensure compliance with Saudi safety regulations through continuous monitoring, reporting, and adherence to local guidelines.

Clinical Trials

Comprehensive CRO services covering site selection, contracting, approvals, patient recruitment, trial management, and safety oversight in the Saudi healthcare system.

Quality Compliance

Our quality services encompass QMS development, investigations, validation, GxP compliance, GMP audits, and ISO certification for robust regulatory alignment.

SFDA Consulting

We provide expert guidance on regulatory compliance, registration pathways, pricing, manufacturing, and distributors, ensuring smooth market access in Saudi Arabia.

Saudi Agent

We operate as a non-commercial local agent for our Biotech & Pharma clients who are new to Saudi Arabia. Also, as an authorized representative for the MedTach companies

Resources

Download Expert-Crafted Resources

Down load the authorized representative agreement for SFDA

Template: Authorised Representative Agreement by SFDA

Checklist Medical Device registration MDMA SFDA

Checklist: SFDA Medical Device Required Files (MDMA)

Checklist of Drug Registration requirements by SFDA

Checklist: SFDA Drug Dossier Requirements

Transfer the Authorised Representative AR in SFDA, Saudi Arabia

Case Study: Transfer of the Authorised Representative (AR)

Regulatory Insights

Your Trusted Regulatory Intel Source

Types of products registration in SFDA (Saudi Arabia)

SFDA Registration and Approval Process

SFDA Medical Device Registration (MDMA)

How to register a drug in Saudi Arabia (SFDA)

SFDA Drug Registration Requirements

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

Pharmacovigilance & QPPV Requirements in Saudi Arabia

orphan drug in Saudi Arabia

Orphan Drug Designation (ODD) in SFDA

Authorized Representative for Medical Device companies in Saudi Arabia

Authorised Representative for Medical Devices in Saudi Arabia

Most Recent

Medical Device Establishment License (MDEL)

SFDA preclinical study submission process in Saudi Arabia

Preclinical Studies Submissions to SFDA

Step-by-step SFDA Drug Master File submission and approval process

Drug Master File (DMF) & Letter of Access for SFDA

Overview of SFDA-accepted economic activities linked to commercial records for regulatory operations

Commercial Record Economic Activities Accepted by SFDA

Illustration of Literature-Based Submission in SFDA

Literature-Based Submissions in SFDA

Biowaiver under SFDA Guidelines for pharmaceutical product registration in Saudi Arabia

Biowaiver Under SFDA Guidelines

Company Updates

News & Announcements

Vision – Clarity – Strength

Partnering with You for Regulatory Success

Leverage our expertise in SFDA regulatory consultation services to make informed, confident decisions. We support you in planning, managing, and executing regulatory projects tailored for the Saudi Arabian market.

  • New market entry experts

  • Registration and SFDA Representation

  • Outsourced regulatory solutions provider
  • GMP/ISO Quality Consultation
  • Local Saudi QPPV service

To meet a consultant, or Request a proposal..

Contact us to schedule a call, request details, or get a tailored proposal.