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
- Trouble-shooting & process optimization of already available formula is also a core function of the product development lab, for the purpose to increase the yield, reduce the manufacturing time. To confirm compatibility of the changes with the technical capabilities of the machines at the customer manufacturing site; these studies are done at each customer site based on the scaling up & post approval changes protocol adopted by the FDA to avoid regulatory re-registration need.
- Technology Transfer: Naratech R&D lab works hand by hand with customers who would like to move their production activities from location to another, by introducing original formula with no / or minimal change in the marketing authorization application that will be accepted by the regulatory authorities. Naratech R&D lab follows this purpose the SUPAC FDA guidelines.
- Development of Freeze-Dried Products, Sterile & Cytotoxic Products.
Naratech R&D Objectives
- Design of effective & efficient formula & manufacturing processes to achieve & maintain product quality & performance.
- Ensure practical & real mechanistic understanding of how formulation & process factors impact product performance.
- Obtain a "real time" assurance of quality.
- Provide specifications set based on science & risk-based.
- Facilitate more regulatory flexibility for post approval continuous improvement (improving productivity & reducing variability).
- Minimize knowledge uncertainty that drives the need for specifications with unnecessarily tight acceptance criteria.
- Provide process understanding to minimize the need for "re-validation" to qualify
- Changes necessary for continuous improvements.
