R&D
Research and development activities, including the development, analysis, transfer, and optimization of generic medicinal products, combine modern equipment, a highly qualified team, and established quality standards. We provide comprehensive lifecycle monitoring of the medicinal products within the extensive portfolio of Antibiotic – Razgrad AD.0+
Registered products in Bulgaria0+
International marketing authorizations0+
Countries with market presence0+
New products registered annuallyFrom Scientific Concept to Market Launch
Idea
We begin with a need for a new generic product or an opportunity to improve an existing formulation within our portfolio.Development
We test and optimize the formulation, develop analytical methods, and monitor stability, quality, and bioequivalence.Registration
We prepare product dossiers, variations, and regulatory strategies in accordance with the requirements of Bulgaria, the EU, and international markets.Transfer
We have a pilot facility for optimization, scale-up, and a smooth transition to commercial manufacturing under controlled conditions.Laboratories
Our research laboratories are a driving force behind innovation in pharmaceutical development. We have a pilot production facility for small-scale development and optimization of manufacturing processes. New formulations are tested there, scale-up activities are carried out, and the transition from laboratory development to production is prepared.
Development, Analysis, and Optimization of Generic Medicinal Products
Analytical methods are developed, validated, and documented. The results obtained are analyzed and used in the preparation of documentation for new marketing authorizations.Core Activities
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- Pharmaceutical development
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- Development, validation, and optimization of analytical methods
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- Monitoring the stability of medicinal products; in-use stability; photostability
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- IVRT and bioequivalence
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- Development of regulatory strategy
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- Preparation of CTD/eCTD dossiers
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- Registration activities for Bulgaria, the EU, and international markets
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- Management of variations and the entire product lifecycle
Analytical Laboratory
The laboratory is engaged in the development, validation, and optimization of analytical methods for the quality testing and bioequivalence assessment of generic products. It is equipped with advanced analytical instrumentation for qualitative and quantitative analysis, stability monitoring, and the generation of data required for regulatory submissions.Laboratory Equipment Includes:
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- IVRT systems for in vitro release testing
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- HPLC (High-Performance Liquid Chromatography) systems for quantitative and qualitative analysis
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- Gas Chromatography (GC) systems for volatile compounds and residual solvents
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- LC-MS systems (Liquid Chromatography with Mass Spectrometry) for structural identification and trace-level analysis
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- Dissolution testing equipment – Distek & Sotax, essential for bioequivalence assessment.
From Laboratory to Manufacturing
The laboratory specializes in the development and analysis of generic pharmaceutical dosage forms, with a focus on tablets, capsules, and ophthalmic drops. Combining modern equipment, a highly qualified team, and established quality standards, we ensure complete lifecycle support for pharmaceutical products that are part of the Antibiotic – Razgrad portfolio.
Our Team
Every development project is supported by a team of experienced pharmacists, chemists, and engineers. Working closely with manufacturing and regulatory specialists, they ensure an efficient and controlled progression from laboratory development to the final pharmaceutical product.