Developing safe & effective pharmaceutical products of well-designed chemical, physical, & biological attributes at lower cost to consumer.
1- Pre-Formulation Studies Phase
This phase will include all required data generated from the work on the raw materials to define the physical-chemical properties & compatibility of the active material with the excipients. All raw material source approval requirements will be included in this phase including DMF(Drug Master File) evaluation which is considered a major element in supplier approval process.
2 - Formulation Studies Phase
This phase will include data generated from the pilot scale studies that are based on the lab scale studies & compatibility testing of active materials with excipients conducted during preformulation phase. Three batches are prepared with the final formula & studied for stability & essential similarity studies with the originators (for generic products) to ensure equivalent safety, efficacy & purity with the developed product.
Scaling up & process validation are conducted on the developed product in the manufacturing site of the customer after the development phase to ensure matching of the developed formula & process of manufacturing with the capabilities & technologies of the production machines at the customer site.
3- Analysis Phase
This phase consists of all needed work for developing & validating analytical methods for both finished product & raw material to evaluate & prove the quality of the developed product as well as ensure compliance of the product to its predetermined specifications.
4- Stability Phase
This phase will include all stability data generated from the accelerated & long term stability testing conducted under all climatic zones conditions that enable compliance to regulatory authorities' requirements for stability testing & will confirm the product quality maintenance during the shelf life of the product.
Other Activities of the R&D Lab
Naratech R&D Objectives