Development

Comprehensive Contract Development and Manufacturing Organization (CDMO) Services.

We integrate cutting-edge research with large-scale production through comprehensive contract development and manufacturing organization (CDMO) services. Equipped with state-of-the-art facilities and an experienced team, guiding each phase of product development while maintaining the highest standards.

We also specialize in developing orphan drugs, complex niche drugs, new chemical entities (NCEs), Abbreviated New Drug Applications (ANDAs), and 505(b)(2) filings, offering tailored solutions from pre-formulation to commercial manufacturing.

Pre-Formulation Studies

Aizant conducts comprehensive pre-formulation studies, including solid-form screening, solubility profiling, particle size analysis, and excipient compatibility testing. These studies form the foundation for successful drug development by optimizing every element before moving to the next stage.

Formulation Development

Our formulation science team develops customized solutions for a wide range of dosage forms, such as tablets, capsules, and complex drug-device combinations. Leveraging advanced technologies such as microspheres, liposomes, and nano-milling, we design innovative drug delivery systems. These systems focus on improved patient compliance and therapeutic outcomes.

Analytical Development & Validation

Providing a complete suite of analytical services, such as HPLC, LC-MS, and dissolution testing, to confirm that formulations meet rigorous standards for purity, stability, and consistency. Our aim is to validate that each product complies with regulatory requirements and is ready for the clinical and commercial stages.

Regulatory Support & Dossier Compilation

With expertise in regulatory affairs, Aizant assists pharmaceutical companies in navigating the complex world of regulatory submissions. From dossier compilation to regulatory filing, we focus on timely and accurate submissions to global agencies such as the FDA, EMA, and others. We also support 505(b)(2) filings, maintaining compliance with local and international regulations throughout the product lifecycle

Commercial Manufacturing

When the product is ready for market release, Aizant offers commercial manufacturing solutions that include packaging, serialization, and distribution. Our facilities are designed to handle large-volume production, with an emphasis on maintaining the highest levels of compliance for orphan and niche drugs.

Pilot Bio Studies &
Scale-Up

Supporting the transition from preclinical to clinical phases, focusing on optimizing formulations for human trials. We prioritize bioequivalence and bioavailability to confirm that the formulations perform effectively in clinical settings. Our scale-up process facilitates a seamless progression from laboratory development to full-scale manufacturing.

Technology Transfer

We facilitate smooth and efficient technology transfer, confirming that products transition seamlessly from the R&D scale to GMP scale followed by commercial production. This includes detailed documentation of manufacturing, packaging, and regulatory processes, making the scaling-up process as efficient and precise as possible.

Expertise in Diverse Dosage Forms

  • Solids: Tablets, capsules, granules, sachets, pellets, chewing gum and specialty release mechanisms such as MR, ER, SR, DR, GR, PR dual release
  • Topicals: Creams, gels, ointments, and lotions designed for targeted delivery.
  • Injectables: Liquid, lyophilized, suspension, and advanced delivery systems such as microspheres and depot injectables.
  • Liquids: Solutions, suspensions, PFOS (parenteral formulations), and customized-release liquid formulations.

Advanced Technologies and Equipment

We leverage state-of-the-art equipment and technology
to support every phase of drug development and
manufacturing:

  • Chromatography & Spectroscopy
  • Nanotechnology
  • AIMLS (Artificial Intelligence and Machine Learning Systems
  • Precision Manufacturing Equipment)

Business Models

We offer flexible business models designed to meet the diverse needs of our clients:

Fee for Service

Our CDMO services are available on a project basis, offering tailored solutions with transparent pricing.

Technology Transfer

We specialize in facilitating smooth transitions from R&D scale to GMP scale,followed by commercial production, managing every detail efficiently

Ready to accelerate your drug development? Let’s connect!