Pharma & Biopharma

Pharma, Biopharma & Advanced Modalities

CRO Services

• Target identification
• Target validation.
• In-silico screening
• Hit-to-lead support
• Lead optimization support.
• In vitro screening
• Assay development.
• Early pharmacology studies,
• Pharmacokinetic/Pharmacodynamic relationship studies
• Bioanalytical support
• New Approach Methodologies (NAMs)

CDMO Services

• Formulation feasibility support for candidate molecules.
• Early process development for API or drug product pathways.
• Analytical method development for development candidates.
• Tech transfer planning from research to development.

CRO Services

• Formulation feasibility support for candidate molecules.
• Early process development for API or drug product pathways.
• Analytical method development for development candidates.
• Tech transfer planning from research to development.

CDMO Services

• Formulation feasibility support for candidate molecules.
• Early process development for API or drug product pathways.
• Analytical method development for development candidates.
• Tech transfer planning from research to development.

CRO Services

• Clinical trial protocol design.
• Site selection and initiation.
• Patient recruitment and retention.
• Clinical monitoring and site management.
• Data management
•  Biostatistics
• Medical Writing.
• Clinical pharmacovigilance
• Trial logistics.
• Preparing regulatory documents for clinical development.
• IND and CTA support.
• Ethics committee or IRB submissions.
• GCP compliance oversight.
• Trial documentation and audit readiness.

CDMO Services

• GMP manufacturing of clinical trial material.
• Packaging and labeling of investigational products.
• Clinical supply chain management.
• Batch release and inventory management for trial supply.
• Support for clinical-stage scale-up and supply continuity.
• GMP quality systems and documentation.
• Validation of manufacturing processes and equipment.
• Batch records, deviation management, and change control.
• Quality control and quality assurance support.
• Regulatory filing support for manufacturing sections of IND, NDA, and MAA submissions

 Nutraceuticals

Nutraceuticals & Functional Wellness

CRO Services

• Ingredient screening
• Efficacy testing.
• In vitro preclinical studies
• In vivo preclinical studies

CDMO Services

• Formula development
• Optimization of formula.
• Raw material selection
• Sourcing support

CRO Services

• Bioavailability and bioequivalence support.
• Safety/toxicology studies

CDMO Services

• Pilot batching
• scale-up.
• Manufacturing of dosage form (powders, capsules, tablets, softgels, liquids, and gummies.)
• Packaging
• Labeling
• Stability testing.

CRO Services

• Clinical trials for health claims
• Protocol design
• Trial monitoring
• Data management
• Statistical analysis.
• Regulatory substantiation support for claims and labeling

CDMO Services

• Quality systems support aligned to food/nutraceutical standards such as HACCP, ISO, and GMP where applicable

 Cosmetics

Cosmetics & Personal Care

CRO Services

• Product safety assessment.
• Dermatological/ophthalmological testing
• Efficacy testing for claims such as hydration, anti-aging, or SPF-related support

CDMO Services

• Formula development
• Formula Optimization
• Ingredient Compatibility Testing

CRO Services

• Human repeat insult patch tests, tolerance tests, and consumer studies

CDMO Services

• Product Scale-up
• Product manufacturing – Gels, creams, emulsions, serums.
• Filling
• Packaging
• Labeling.
• Stability testing.
• Tech transfer from lab to production

CRO Services

• Claim substantiation and regulatory documentation support.

CDMO Services

• GMP-based production
• Quality control

 Medical Devices

Medical Devices & Combination Products

CRO Services

• Concept feasibility studies.
• Preclinical testing
• Bench testing

CDMO Services

• Design and development support.
• Prototype production

CRO Services

• Biocompatibility studies
• Usability studies
• Human factors studies

CDMO Services

• Pilot production
• Device assembly
• Sterilization support
• Packaging.
• Manufacturing scale-up.
• Verification and validation support

CRO Services

• Clinical investigations
• Post-market clinical follow-up.
• Regulatory dossier support

CDMO Services

• Documented quality management and manufacturing controls

 Animal Health

Animal Health & Veterinary

CRO Services

• Target identification
• Lead optimization.
• In vitro safety
• In vitro efficacy studies

CDMO Services

• API -manufacturing
• Formulation development and optimization
• Feed optimization

CRO Services

• Species-specific safety and efficacy studies
• Toxicology Studies

CDMO Services

• Finished-dose manufacturing
• Scale-up.
• Stability Testing

CRO Services

• Veterinary clinical trials.
• Bioanalysis
• Data management
• Regulatory consulting.
• Post-approval research and field studies

CDMO Services

• Quality Control
• Ensure GMP-compliance

Agrochemicals

Agrochemicals & Crop Protection

CRO Services

• Efficacy screening of active ingredients

CDMO Services

• Formulation development and optimization for herbicides, fungicides, insecticides, and specialty crop inputs

CRO Services

• Toxicology studies
• Ecotoxicology studies.
• Residue analysis
• Environmental fate studies

CDMO Services

• Scale-up.
• Manufacturing and blending.
• Packaging
• Labeling
• Storage
• Stability testing.
• Supply-chain support for commercial and trial batches

CRO Services

• Crop protection field trials.
• Regulatory data generation for product registration.
• Safety and risk assessment support

CDMO Services

• Quality control tests