Biotech – Pharma – MedTech

Streamlining SFDA Compliance

Regulatory and Pharmacovigilance Consulting Services, provided by Industry Experts and Former SFDA Consultants

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10-12 December 2024, Riyadh. Saudi Arabia

Exhibiting in CPHI Middle East (Booth 4.A1)

Visit our booth in CPHI Middle East. Meet our team and discuss future opportunities in the Saudi market.

Meet us in CPHI

About

Charting the Path to Regulatory Excellence

PharmaKnowl was founded by Mohammed Jobran, a regulatory affairs expert, guiding businesses in the life science industry.

20+ years of regulatory affairs experience.
Former Saudi Food and Drug Authority (SFDA) chief regulatory Pharmacist.
Former regulatory and scientific office manager for a multinational company.
Expert in regulatory projects such as mergers & acquisitions, licensing, manufacturing, pricing, new market entry, and technology transfers.
Expert in product registration, marketing rights, import and manufacturing, and developing technical files.
Pharmacist (BSc), Biomedical Informatics (MSc)

Mohammed Jobran

Pharmacist (BSc), Biomedical Informatics (MSc)

Pharma Clients

MedTech Clients

Passionate – Dedicated – Professional

Regulatory Strategy

Empower your decision-making by utilizing our experience in SFDA consultations, Saudi market research, and our insightful regulatory opinion. We guide, plan, and implement your regulatory projects in the Saudi Arabia market.

New access to the Saudi market
Drug price evaluation
Representations and authority Meetings

about us

Consult – Support – Deliver

Comprehensive Solutions for Regulatory Success

We simplify the complexities of regulatory compliance and streamline your path to marketing advantage.

Regulatory Affairs

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

Regulatory Projects & Operations

Pharmacovigilance

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

Third Party Service Provider

SFDA Consulting

Expert guidance on regulatory compliance, registration pathways, pricing, manufacturing, distributors, and approval, ensuring smooth market access in Saudi Arabia.

Regulatory and Business Strategy

Market Entry

We simplify Saudi market entry for Pharmaceutical, BioTech, and MedTech companies by guiding and clarifying different entry routes, planning, and executing.

Entry Routes and Conditions

Quality Compliance

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

PIC/S and ISO Compliance

Representation

Operating as a non-commercial agent & authorised representative to support our partners’ activities and interact with the authorities on behalf of international companies.

Independent and Direct Communication

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Expertise – Trust – Excellence

Our Strengths, Your Regulatory Advantage

We bring together expertise, versatility, and trust to deliver exceptional regulatory solutions. Our team’s qualifications, cross-sector experience, in-depth knowledge, and credibility empower your business to meet compliance challenges with confidence and efficiency.

Cross-Sector Experience

Equipped with SFDA
and industry experience,
providing insights
for planning, decision making,
and strategy.

Knowledge

Updated with the latest
regulations and related
market dynamics information
to provide solid opinion
and regulatory intelligence.

Qualified

Licensed pharmacists
and biotechnologists with
deep regulatory experience
in various types of products
and life science industries

Credibility

Trusted
by big pharma
and BioTech companies, providing strong local partnership and authorised representation.

Regulatory Resources

latest news & insights

Read our guidance articles and summaries of SFDA guidelines and related laws for the Pharmaceutical and MedTech industries.

Send your query or request a Meeting.

Find answers to your regulatory questions to help you take the right decision. Send your queries or request an online meeting to discuss your upcoming project.

Call us for inquiry : Sunday to Thursday: 9 am – 5 pm

+966-11-2777729

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