Pharmaceutical Regulatory Affairs Consulting

What we do: PKCS provides end-to-end pharmaceutical regulatory affairs consulting for Iraq, the UAE, Saudi Arabia, and the wider GCC. We prepare and submit dossiers to the Iraqi Ministry of Health, MOHAP/EDE in the UAE, the Saudi SFDA, and the GCC central drug registration pathway, and we manage the full product lifecycle — from initial marketing authorization through variations, renewals, and withdrawals.

What is regulatory affairs consulting and who needs it?

Regulatory affairs consulting is the discipline of bringing a pharmaceutical, biotechnology, or medical device product to market in compliance with national and regional regulations. For manufacturers entering Iraq or the GCC, the work includes interpreting national requirements, preparing the technical dossier in the format the authority expects (eCTD where supported, country-specific templates elsewhere), submitting through the right channel, and responding to deficiencies until marketing authorization is granted.

PKCS supports innovator pharmaceutical companies, generics manufacturers, biotech firms, contract research organizations, and medical device manufacturers. Foreign manufacturers without a local presence in Iraq, the UAE, or Saudi Arabia rely on PKCS as the regulatory expert and, where required, the local agent or marketing authorization holder of record.

Which authorities does PKCS file with?

• Iraq — Iraqi Ministry of Health (MOH), Iraqi Drug Regulatory Authority (IDRA), and the State Company for Marketing Drugs and Medical Appliances (KIMADIA). See Drug Registration in Iraq for the country pathway.
• United Arab Emirates — Ministry of Health and Prevention (MOHAP) and the Emirates Drug Establishment (EDE), under the framework of UAE Federal Decree-Law 38/2024. See UAE MOHAP & EDE Drug Registration.
• Saudi Arabia — Saudi Food and Drug Authority (SFDA). See Saudi SFDA Drug Registration.
• GCC central pathway — Coordinated registration through the GCC Health Council, with reciprocal recognition across Saudi Arabia, the UAE, Kuwait, Qatar, Bahrain, and Oman.
• Other regional authorities — Egyptian Drug Authority (EDA), Jordan FDA, and other MENA regulators on a project basis.

What does PKCS deliver in a regulatory affairs engagement?

A typical regulatory affairs engagement covers regulatory strategy and gap assessment, dossier compilation in the format the receiving authority expects, technical and administrative review against country-specific checklists, translation of labelling and patient information leaflets into Arabic, submission to the regulator, deficiency response management, post-approval lifecycle activities (variations, renewals, transfers of marketing authorization), and ongoing regulatory intelligence on changes that affect the registered product.

For products already registered in the EU, US, or other reference markets, PKCS works from the existing global dossier and adapts it to GCC and Iraqi requirements rather than rebuilding it from scratch — preserving the regulatory history and shortening time to approval.

How long does regulatory affairs work take?

Timelines depend heavily on the country, product class, and dossier completeness. As a directional guide, Iraq MOH approval for a new generic, with a complete dossier and qualified Arabic labelling, typically runs 9–18 months from first submission to marketing authorization. UAE MOHAP/EDE timelines vary by accelerated vs standard pathway and product novelty. The fastest path for innovator products is usually the SFDA verification pathway when the product is already approved in a reference authority. PKCS provides realistic, country-specific timelines as part of the initial gap assessment.

Related services

• Drug Registration in Iraq — MOH, IDRA, and KIMADIA filings for the Iraqi market.
• UAE MOHAP & EDE Registration — Drug registration under UAE Federal Decree-Law 38/2024.
• Saudi SFDA Registration — SFDA marketing authorization and lifecycle management.
• Pharmacovigilance Services — PV system setup, QPPV, and adverse event reporting across MENA.

Frequently asked questions

What is included in a regulatory affairs consulting engagement?

Regulatory strategy, gap assessment against country requirements, dossier compilation, Arabic labelling, submission, deficiency response, and post-approval lifecycle management. PKCS scopes each engagement around the specific product, target countries, and existing regulatory history.

Can PKCS act as the local agent or marketing authorization holder?

Yes. For markets that require a locally licensed entity to hold the marketing authorization or act as the regulatory point of contact, PKCS provides local representative services in Iraq, the UAE, and other GCC markets.

Do you support medical device registration in addition to pharmaceuticals?

Yes. PKCS supports medical device classification under GHTF rules, registration with MOHAP and the SFDA medical devices department, and the related quality system requirements (ISO 13485). Engagements are scoped to the device risk class.

How does PKCS handle dossiers already approved in the EU or US?

Most regional authorities recognize approvals from reference markets. PKCS uses the existing global dossier, adds the country-specific administrative and Arabic labelling components, and submits via the appropriate verification or accelerated pathway where one exists. This is faster and lower-risk than rebuilding the dossier.