Pharma Materials and Supply Services
- We can be your extended partner for your outsourcing activities, such as materials procurement and supply management solutions which will help reduce costs in the workforce, sourcing database acquisition, and procurement processing time.
- Efficient logistics support in the supply chain cycle ensures on-time deliveries.
- We offer practical solutions during clients & development of new products and alternative suppliers &
development. - Stringent support on regulatory requirements ensures that you meet the respective health authority regulations in documentation, queries, analytical requirements, and timely registration of your products.
Sourcing and supply of pharmaceutical raw materials such as active ingredients, pellets, inactive ingredients, specialty excipients, and empty gelatin capsules
- We partner only with reputable sources to ensure full compliance with regulatory requirements for Inactive Ingredients, such as ISO or GMP certificates, TSE/BSE Certificate, Excipient Drug Master File, and any other specific requirements required by a particular health authority.
Support for licensing, ready dossiers, and technology transfer
- We assist with or customize strategic product development and launching approaches for our clients, such as serving them for in-licensing, ready dossiers, or technology transfer to enable them to be in the market at the earliest possible time.
We partner only with renowned manufacturers that comply with Saudi Food & Drug Authority (SFDA) regulations in supplying semi-finished or finished products for local secondary, final packaging, or distribution operations until complete local manufacturing is implemented per the timeline authorized by the SFDA.
- We have existing licensing partners and are ready for business transactions that we can reveal to our clients only after signing confidentiality and service agreements.
Support in sourcing reputable manufacturers for generic APIs, ready-to-fill pellets, and directly compressible (DC) granules; we ensure that:
- Our partners are reputable manufacturers of all sizes that can provide our customers with high-quality products at reasonable prices, in full compliance with regulatory health authority requirements.
- Technical requirements for our customers’ development, approval, and registration of their finished product are well supported, including but not limited to open-part of DMF in CTD format (as the standard drug master file requirement), Set of Impurities, the Working Standard required in initial laboratory testing, LOAs, WHO-GMP Certificate, and CEP or USDMF depending on market regulatory requirements.
We can support companies that do not have full R&D capabilities, such as by finding alternative strategic solutions to develop, register, and launch products at the earliest possible time through our reliable third-party partners for the following business concepts:
- Contract research and manufacturing services (CRAMS), also called contract development and manufacturing organizations (CDMO), is a comprehensive single-source provider from drug development through commercial manufacturing that has emerged in recent years. CRAMS is one of the fastest-growing segments in the pharmaceutical and biotechnology industry.
- A contract research organization (CRO) provides all research and development services, and a contract manufacturing organization (CMO) focuses on manufacturing services outsourced on a contract basis.
Supplier audit management
- We have a highly experienced and qualified team that serves as an independent third party in performing GxP audits of your local and global suppliers to evaluate and qualify their manufacturing capacities, quality management system (QMS), structural environment, and health and safety (EHS) impact.
Management of contractors and vendors
- We can provide assistance and solutions for best industry practices to manage your contractors and vendors, ensuring that they deliver the sub-contract services according to your needs and the regulations of local health authorities.
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