Dedicated state-of-the-art Phase-I units in Ahmedabad (India), Toronto (Canada) & Novum (USA) enable us to have a synergistic approach across geographies for timeline and cost advantages. Till date, Lambda has successfully executed over 43 phase-1 studies in the last 5 years for various formulations including Oral, Parenteral, Inhalers, Topical, Transdermal, Nasal Sprays, Injectables, Pessaries, Suppositories etc.
Lambda has strong technical expertise in handling studies like:
- Single Ascending Dose (SAD) - First in Man
- Multiple Ascending Dose (MAD)
- BA/BE Bio comparison
- Drug-Drug Interaction
- Food-Drug Interaction
- PK-PD
- Proof-of-concept
- Irritation, Sensitization, Adhesion
- Cardiac Safety
- Vasoconstrictor Studies for Topical Cortico steroids
- Special Patient Populations
- Potency Ranking Studies
- Drug-Device Combinations
- Food Effect Studies
NCE Therapeutic Categories
Analgesics
Anticonvulsants
Antidepressants
Anti–inflammatory Agents
Antiviral
Antibacterial
Antidementia Agents
Antifungal
Antimigraine Agents
Blood Glucose Regulators
Blood Modifiers
Cardiovascular Agents
Central Nervous System Agents
Dermatological Agents
Gastrointestinal Agents
Hormonal Agents
Immunological Agents
Ophthalmic Agents
Respiratory Agents
Vaccines
Phytopharmaceuticals
Inflammatory Bowel Diseases
Antiretrovirals
Value Proposition
NORTH AMERICA
- FiH Or SAD study in Canada & US
- Faster regulatory approval
- Parallel submission for MAD study in India
- Study starts with healthy subjects followed by patient cohorts
INDIA
- Cost-effective option for subsequent Phase-1 studies
- Easier Access for Renal and Liver impaired subjects study
VALUE PROPOSITION
- Cost-effective business model (Hybrid)
- Faster Turn Around Time
- Global scientific overview
- Flexible Operational approach