Our multidisciplinary consultants will help you to shorten approvals time in the MENA region, in addition you can outsource to our internal and external experts, as they possess extensive experience in MENA countries regulatory requirements.
SIPS compliance management services help our clients to maximize their product value and protecting it, by mitigating risks associated with its life cycle.
Our qualified consultants, including industry experts and former inspectors possess the know how of regulatory requirements in the MENA region, with proven records in managing complex regulatory issues.
Pharmacovigilance & Risk Management Our team specialized in pharmacovigilance will help you to: • PV database management, bibliographic searches, safety documentation and reports • Preparation of safety specific documentation
SIPS works with EXTEDO to provide and support EXTEDO’s software in the following areas • Submission Creation & Lifecycle Management • Submission Reviewing & Validation • Pharmacovigilance Management • Computer System Validation
We specialize in the fields of regulatory, compliance, market access and intellectual property services with experience in Middle East countries and selected International markets. Our multidisciplinary consultants will help you access the dynamic and changing Middle East markets by shortening approval time of your products. Our internal and external experts possess extensive experience in Middle East & North Africa (MENA) countries regulatory requirements for best result achievement.
Pharmaceuticals Biologics and biotechnology Medical devices Nutraceutical products Cosmetics Veterinary products API products
Clients reviews
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Dr. Mohammed Al Rubaie
Director of Drug Control
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Dr. Hamdy Abdulrahman
Regulatory Affairs & Registration
We submitted five dossiers to SFDA after getting training by SIPS and all were accepted, in this regard I want to thank you a lot for your professional training.
The EXTEDO suite supports the critical relationship between the pharmaceutical industry and regulatory authorities, ensuring that your life sciences business operates a compliant and efficient product registration and maintenance process...