Outsourcing Services Overview for KSA, GCC, MENA, and Iraq
Our company specializes in providing comprehensive outsourcing solutions across the pharmaceutical industry, offering a full spectrum of services tailored to the specific needs of KSA, GCC, MENA, and Iraq. Our expertise spans multiple domains, ensuring that our clients achieve regulatory compliance, operational efficiency, and market success.
Registration Services:
- We manage the entire process of product registration, including the preparation, submission, and follow-up of regulatory dossiers.
- Our team ensures compliance with local regulations, facilitating a smooth approval process for pharmaceuticals, biologics, and medical devices.
- We handle both initial registrations and renewals, ensuring that your products remain compliant throughout their lifecycle.
Technology Transfer and Contract Manufacturing:
- We provide end-to-end support for technology transfer projects, ensuring a seamless transition of manufacturing processes between sites.
- Our services include detailed project planning, coordination with all stakeholders, and strict adherence to regulatory requirements.
- We ensure that the transferred technology is fully compliant with the standards of the Saudi FDA and other relevant authorities in the GCC, MENA, and Iraq.
GMP Inspection and Pre-Audits:
- We conduct thorough GMP inspections to ensure that manufacturing sites meet all regulatory requirements and quality standards.
- Our pre-audit services help identify potential compliance issues before official inspections, reducing the risk of costly delays and penalties.
- We provide detailed audit reports and actionable recommendations to help you maintain compliance.
Bioequivalence Registration and Renewal:
- We manage the registration and renewal of bioequivalence studies, ensuring that your products meet the required standards for market approval.
- Our services include dossier preparation, regulatory submission, and ongoing compliance management.
- We work closely with regulatory authorities to expedite the approval process and ensure that your products remain on the market without interruption.
Partnership in All Pharmaceutical Activities:
- We facilitate strategic partnerships across the pharmaceutical value chain, including research and development, clinical trials, and commercialization.
- Our services are designed to foster collaboration between local and international stakeholders, ensuring mutual benefits and successful outcomes.
Contract Manufacturing Organization (CMO) Partnerships:
- Our extensive network of CMO partnerships allows us to offer flexible and scalable manufacturing solutions tailored to your specific needs.
- We ensure that all CMO partners comply with Good Manufacturing Practices (GMP) and meet the highest quality standards.
- Our services cover the entire manufacturing process, from raw material sourcing to final product packaging and distribution.
Market Research & Market Analysis:
- Our market research services provide comprehensive insights into market trends, competitive landscapes, and customer preferences across KSA, GCC, MENA, and Iraq.
- We deliver data-driven analysis to support strategic decision-making, product development, and market entry strategies.
- Our services are tailored to help you identify growth opportunities and mitigate risks in a competitive market.
Engineering Activities:
- We provide a full range of engineering services to support pharmaceutical manufacturing, including facility design, equipment validation, and process optimization.
- Our team ensures that all engineering activities comply with GMP and other regulatory standards, providing a solid foundation for efficient and compliant operations.
- We also offer ongoing support for facility upgrades and expansions, helping you maintain operational excellence.
