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Innovex

Dedicated to transforming health through cutting-edge pharmaceutical innovation, ensuring safer, more effective treatments for a better tomorrow.

About Company

Awesomedge Innovex

At Awesomedge Innovex, we are more than a contract research partner—we are a global think tank of scientific excellence. Our team of seasoned experts, each with an average experience of 30 years, brings unmatched depth in toxicology, regulatory science, and GLP-compliant practices. With every project, we strive to create meaningful scientific outcomes that meet the highest regulatory expectations.

Our state-of-the-art research facility supports a complete suite of services in:

  • Ecotoxicology
  • Genotoxicology
  • In Vitro Toxicology
  • Safety Pharmacology
  • Regulatory Dossier Support and Study Design
    • We proudly support the cosmetic, nutraceutical, agrochemical, pharmaceutical, and medical device sectors, offering bespoke solutions aligned with the guidelines of OECD, FDA, EPA, OPPTS, CIBRC, ECHA (REACH), ICH, ISO, and more.

Our Commitment to Scientific Innovation

At Awesomedge Innovex, every day is a day of progress. We are continually:

  • Developing animal-free in vitro models that advance the 3Rs (Replacement, Reduction, Refinement)
  • Expanding services to meet the evolving needs of global industries and regulators
  • Innovating with advanced platforms in cell-based assays, organ-on-chip, hERG, high-content imaging, and 3D models
  • Designing tailored studies with full regulatory alignment for IND/NDA/ANDA/510(k)/PMDA submissions

Why Awesomedge Innovex?

🧠 30+ years of scientific leadership

🧪 GLP-certified studies across domains

🌍 Full regulatory alignment: FDA, OECD, OPPTS, CIBRC, EMA, REACH

🧬 Experts in in vitro, ecotoxicology, genotoxicology, and hERG assay

🌱 Pioneers in non-animal science, committed to the 3Rs

🌿 Ecotoxicology

Full Regulatory Compliance with OECD, EPA, OPPTS, and CIBRC

We offer a comprehensive range of ecotoxicology studies in alignment with global regulations. All studies are conducted under OECD GLP standards and tailored to the requirements of OECD, EPA, OPPTS 850 Series, CIBRC (India), REACH, and FDA Environmental Assessment (EA).

OECD Ecotoxicology Guidelines Supported:
Aquatic Toxicity Tests

  • OECD TG 201 – Alga, Growth Inhibition Test
  • OECD TG 202 – Daphnia sp. Acute Immobilisation Test
  • OECD TG 203 – Fish, Acute Toxicity Test
  • OECD TG 204 – Fish, Prolonged Toxicity Test
  • OECD TG 210 – Fish, Early-Life Stage Toxicity Test
  • OECD TG 211 – Daphnia magna Reproduction Test
  • OECD TG 212 – Fish, Short-term Toxicity Test on Embryo and Sac-fry Stages
  • OECD TG 215 – Fish, Juvenile Growth Test
  • OECD TG 229 – Fish Short-Term Reproduction Assay
  • OECD TG 230 – 21-day Fish Screening Assay
  • OECD TG 234 – Fish Sexual Development Test
  • OECD TG 236 – Fish Embryo Acute Toxicity (FET) Test
  • OECD TG 305 – Bioaccumulation in Fish

Sediment and Terrestrial Toxicity

  • OECD TG 207 – Earthworm, Acute Toxicity Test
  • OECD TG 208 – Terrestrial Plants, Growth Test
  • OECD TG 220 – Enchytraeid Reproduction Test
  • OECD TG 222 – Earthworm Reproduction Test
  • OECD TG 226 – Lemna sp. Growth Inhibition Test
  • OECD TG 232 – Collembolan Reproduction Test
  • OECD TG 233 – Sediment-Water Lumbriculus Toxicity Test

Biodegradation and Transformation Studies

  • OECD TG 209 – Activated Sludge, Respiration Inhibition Test
  • OECD TG 301 A–F – Ready Biodegradability
  • OECD TG 302 A/B/C – Inherent Biodegradability
  • OECD TG 303 A/B – Simulation Test: Aerobic Sewage Treatment
  • OECD TG 304 A/B – Biodegradation in Aquatic Sediment Systems
  • OECD TG 308 – Aerobic and Anaerobic Transformation in Aquatic Sediment Systems
  • OECD TG 309 – Aerobic Mineralisation in Surface Water

Vegetative/Crop Safety and Metabolism (Plant Metabolism Studies)

  • OECD 501–508 – Plant Metabolism and Fate
  • EPA OPPTS 860.1300 – Nature of the Residue (Plants)
  • OPPTS 860.1340 – Confined Accumulation Studies
  • OPPTS 860.1500 – Crop Field Trials
  • OPPTS 860.1520 / 860.1540 – Processing and Storage Stability
  • OECD 227 – Vegetative Vigor Test
  • OECD 208 – Seedling Emergence
These studies support MRL determination, consumer exposure, GAP development, and CIBRC registrations.

🐄 Livestock Studies

(Animal Metabolism, Residue Depletion, Veterinary Toxicology)

At Awesomedge Innovex, every day is a day of progress. We are continually:

  • OECD 505–508 – Livestock Metabolism and Residue Studies
  • EPA OPPTS 860.1380 – Nature of Residue in Livestock
  • OPPTS 860.1480 – Animal Feeding Studies
  • VICH GL33 / GL46 / GL49 – Veterinary Drug Residue Depletion Studies
  • FDA CVM Guidelines – Tolerances, ADIs, Target Animal Safety

◉ We offer target species toxicity testing, milk/meat residue depletion, and marker residue analysis for veterinary pharmaceuticals and feed additives.

◉ We meet the needs of global agrochemical and industrial chemical registrations, including EPA OPPTS 850 Series guidelines for ecological effects and CIBRC protocols under the Insecticides Act.

🧬 In Vitro Toxicology

Where Models Meet Precision

We are proud leaders in custom in vitro assay development, offering regulatory-aligned solutions for product safety and efficacy. Whether it’s cosmetic irritation, drug-induced hepatotoxicity, or skin sensitization, we design and validate models based on OECD TGs, ISO 10993, FDA Redbook, and ICH guidelines.

OECD In Vitro Toxicology Guidelines Offered:

  • OECD TG 431 – In Vitro Skin Corrosion: Human Skin Model Test
  • OECD TG 439 – In Vitro Skin Irritation: Reconstructed Human Epidermis Test
  • OECD TG 492 – Reconstructed Human Cornea-like Epithelium Test Method (Eye Irritation)
  • OECD TG 437 – Bovine Corneal Opacity and Permeability Test (BCOP)
  • OECD TG 438 – Isolated Chicken Eye Test
  • OECD TG 432 – 3T3 NRU Phototoxicity Test
  • OECD TG 442A/B/C/D/E – Skin Sensitization (DPRA, KeratinoSens™, h-CLAT, U-SENS™)
  • OECD TG 428 – Skin Absorption: In Vitro Method

Applications include:

  • 3D reconstructed tissues (epidermis, airway, cornea, GI tract)
  • Barrier integrity & permeation assays
  • High-throughput cytotoxicity & apoptosis assays
  • Neurotoxicity, hepatotoxicity, nephrotoxicity models
  • iPSC-derived human cardiomyocytes
  • Blood–brain barrier & inhalation models
  • ISO 10993 biocompatibility suite (cytotoxicity, irritation, sensitization)
We are constantly developing new models for emerging product classes, aligning with the industry’s shift towards non-animal testing.

🔬 Genotoxicology

In Vitro Excellence for Global Dossiers

Awesomedge Innovex is a leading provider of in vitro genotoxicity studies, compliant with OECD TGs, ICH S2(R1), FDA Redbook, REACH, and more.
In Vitro Genotoxicology Test Battery:

  • Ames Test (Bacterial Reverse Mutation Test) – OECD TG 471
      • • Salmonella typhimurium and E. coli strains ± S9
  • In Vitro Mammalian Chromosome Aberration Test – OECD TG 473
      • • Human lymphocytes or CHO cells
  • In Vitro Mammalian Cell Gene Mutation Test (HPRT/XPRT) – OECD TG 476
  • In Vitro Micronucleus Test – OECD TG 487
      • • For clastogenic and aneugenic potential
  • Mouse Lymphoma Assay (MLA/TK Assay) – OECD TG 490
  • 6. Comet Assay (Single Cell Gel Electrophoresis) – For DNA strand breaks (Emerging, based on validation protocols)

We ensure results are regulatory-ready for FDA, EMA, PMDA, and CIBRC filings.

⚠️ Safety Pharmacology

hERG and Beyond

We provide specialized in vitro safety pharmacology testing, including cardiac, neurological, and respiratory endpoints.

Key Assays:

  • hERG Assay (Human Ether-à-go-go Related Gene)
      • • Patch-clamp or fluorescence-based
      • ICH S7B and FDA-compliant
      • Detects QT interval prolongation risk
      • Suitable for IND/NDA regulatory filings
  • iPSC-derived cardiomyocyte-based cardiac assays
  • Neurotoxicity screening (calcium imaging, MEA systems)
  • Respiratory and CNS functional assays (as per ICH S7A)
All safety pharmacology assays are conducted in accordance with GLP, ICH, and FDA guidelines.

🌐 Global Regulatory Compliance

We support submissions to:

  • FDA (CDER, CBER, CDRH)
  • EPA and OPPTS 850/870/890 series
  • CIBRC – India
  • REACH (ECHA)
  • EU Cosmetic Regulation (1223/2009/EC)
  • ICH (S2, S7A, S7B, M3, Q3C)
  • ISO 10993 Series for Medical Devices

Let’s Build the Future of Safer Innovation—Together.

Awesomedge Innovex – Where Science Meets Purpose. We don’t just deliver studies. We deliver trust, strategy, and regulatory confidence.