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Research & Development Lab

Naratech Product Development Phases

Naratech Laboratory creates product files that are supplied to pharmaceutical companies throughout the MENA region, USA and Europe. Product development work is carried out in careful steps according to current FDA/EU cGMP regulations for product development.

Our goal is to develop safe and effective pharmaceutical products with well-designed chemical, physical and biological properties at lower cost to consumers.

1- Pre-Formulation Studies Phase

This phase includes all necessary data obtained from the work on raw materials to define the physicochemical properties and compatibility of the active ingredient with excipients. All raw material source approval requirements are considered in this phase, including the DMF (Drug Master File) evaluation, which is considered an important element of the supplier approval process.

2 - Formulation Studies Phase 
In this phase, data is obtained from the pilot studies based on the laboratory studies and compatibility tests of the active ingredients with excipients conducted in the pre-formulation phase.  Three batches are prepared with the final formula and studied for stability and essential similarity studies with the originators (for generic products) to ensure equivalent safety, efficacy and purity with the developed product.

After the development phase, scale-up and process validation are performed on the developed product at the customer's production facility to ensure that the developed formulation and manufacturing process match the capabilities and technologies of the production machinery at the customer's site.

3- Analysis Phase
This phase includes all the work required to develop and validate analytical methods for both the final product and the raw material, in order to evaluate and demonstrate the quality of the developed product and to ensure that the product conforms to the given specifications.

4- Stability Phase 
This phase includes all stability data obtained from accelerated and long-term stability testing conducted under all climatic conditions to meet regulatory stability testing requirements and to confirm maintenance of product quality during the shelf life of the product.

Other Activities of the R&D Lab

  • Troubleshooting & process optimization of existing formulas is also a core function of the product development laboratory to increase yield and reduce manufacturing time. To confirm the compatibility of the changes with the technical capabilities of the machines at the customer's production site, these studies are conducted at each customer site based on the FDA-adopted protocol for scaling-up and post-approval changes to avoid re-registration by the authorities.
  • Technology Transfer: Naratech's R&D lab works hand-in-hand with customers who wish to move their production to another location by incorporating the original formulation with no or minimal changes into the regulatory submission that is accepted by the regulatory authorities. Naratech's R&D laboratory follows SUPAC FDA guidelines for this purpose.
  • Lab testing for all dosage form according to ISO 17025 : 2017

Naratech R&D Objectives

  1. Develop effective and efficient formulations and manufacturing processes to achieve and maintain product quality and performance.
  2. Ensure a practical and true mechanistic understanding of the impact of formulation and process factors on product performance.
  3. Obtain a "real time" assurance of quality.
  4. Provide specifications set based on science and risk-based information.
  5. Facilitate greater regulatory flexibility for continuous post-approval improvements (improving productivity and reducing variability).
  6. Minimize knowledge uncertainty that leads to the need to create specifications with unnecessarily narrow acceptance criteria.
  7. Provide an understanding of the processes to minimize the need for "re-validation" for qualification of changes necessary for continuous improvement.