Customized Testing Solutions

Tailored analytical and safety testing for complex, novel, or niche products.

At IIBAT, we understand that not all products fit neatly into regulatory templates or standard protocols. Our Customized Testing Solutions are designed for clients developing innovative formulations, specialty chemicals, complex mixtures, or first-in-class products that demand adaptable, scientifically rigorous approaches.

Whether you’re working with a novel active ingredient, designing a unique delivery system, or entering a highly regulated market, we help you generate precise, defensible data—exactly as needed.

🧪 Why Custom Testing Matters

Many regulatory pathways require non-standard, fit-for-purpose testing due to:

  • Novel mechanisms of action or formulation types
  • Lack of existing reference methods or standards
  • Early-phase discovery requiring method development
  • Product categories with overlapping or evolving guidelines

IIBAT offers you access to an integrated platform combining method development, specialized toxicology, advanced analytical techniques, and regulatory support.

⚙️ Our Customized Testing Services

We provide tailored analytical, toxicological, and regulatory solutions for non-standard, novel, or complex products. From method development to study design, our custom testing capabilities help you navigate unique regulatory challenges and accelerate product innovation.

1. Method Development & Validation

Objective: Build analytical methods that are specific, sensitive, and reproducible for your unique compound or formulation.

Capabilities:

  • Development of HPLC, GC, LC-MS/MS, UV, ICP-MS methods
  • Custom matrices (e.g., blood, plasma, skin, soil, air, leachables, wastewater)
  • Full validation per ICH Q2(R1) or USP <1225>
  • Forced degradation & stability-indicating method development
  • Limit test methods for impurities or trace elements

✅ Ideal for non-compendial APIs, excipients, delivery systems, and biopolymers

2. Specialized Testing for Agrochemicals, Biocides & Industrial Chemicals

Objective: Evaluate performance, safety, and compliance of challenging or novel substances.

Services include:

  • Slow-release, nano-formulated, or microencapsulated products
  • Seed coatings, adjuvants, and tank mixes
  • Non-traditional active ingredients (e.g., botanicals, pheromones, RNA-based biopesticides)
  • Physical–chemical characterisation for transport & labelling (e.g., flash point, pH, stability)
  • GLP-compliant testing of combination products or dual-action formulations

✅ Custom protocols based on EPA, REACH, or CIB&RC data requirements
✅ Supports innovation in pest control and plant health

3. Advanced Analytical Testing

Objective: Deliver high-precision data for complex samples or regulatory review.

Capabilities:

  • Trace-level impurity detection (ng/mL to ppb level)
  • Polymorph and crystal structure analysis (PXRD, DSC)
  • Residual solvent & monomer profiling
  • Extractables & leachables from non-standard materials
  • Degradation product identification (LC-MS/MS, Q-TOF)

✅ Often required for complex injectables, inhalers, combination products, or novel packaging materials

4. Formulation-Specific Testing

Objective: Support the development of complex dosage forms and delivery platforms.

Services for:

  • Topicals, transdermals, and cosmetics (e.g., irritation potential, absorption, rheology)
  • Inhalable formulations (particle size, emitted dose uniformity)
  • Injectables & suspensions (sterility, particle characterisation, rheology)
  • Gels, creams, ointments, patches (viscosity, in vitro release testing)
  • Controlled-release formulations (dissolution, in vitro–in vivo correlation)

✅ Custom protocol development + validation
✅ Designed in line with FDA/EMA expectations and pharmacopoeial references

5. High-Purity & Specialized Materials Testing

Objective: Ensure identity and purity of materials for high-risk or regulated applications.

We test:

  • High-purity intermediates (residual solvent, heavy metals, water content)
  • Reagents and catalysts
  • Cosmetic raw materials and natural extracts
  • Excipients for parenteral use
  • Polymers for implantable devices or packaging

✅ GMP or GLP-compliant testing available
✅ Custom CoA and specification development support

6. Integrated Consulting & Problem Solving

Objective: Deliver actionable insights when off-the-shelf testing won’t do.

We provide:

  • Cross-functional scientific consulting (analytical, formulation, toxicology, regulatory)
  • Feasibility studies and test method design
  • Support for investigational new product development
  • Bridging strategies and study design to fill data gaps
  • Assistance with waiver justification and scientific rationales

✅ Perfect for R&D pipelines, early-stage innovators, or complex reformulations

Why Choose Us?

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State-of-the-art instrumentation and multi-disciplinary scientific team

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Deep regulatory insight across regions and product classes

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Flexible testing models tailored to your product’s science and market strategy