Raptim Research Private Limited, is a global independent and internationally accredited Contract Research Organization (CRO) providing full-service for early and late phase clinical research, with 16 years of experience.
Raptim Presence
Mumbai
(Maharashtra, India)
Head Office,
Operations
Head Office,
Operations
Gandhinagar
(Gujarat, India)
Operations
Operations
New Jersey
(USA)
Marketing
Marketing
Our Services
BA/BE
- Healthy Subject (Bioequivalence &
Bioavailability) Studies- Completed 1600+ BA/BE studies
- 35000+ Volunteer Database (Inclusive of Healthy Male/Female, Post Menopausal Female, Elderly Population)
- Expertise in Complex studies of Inhalation Products, Transdermal System, Narcotics and Psychotropic Substances, Vaginal Ring and Vitamins etc
- 505(b)2 Studies
- Patient Based Studies
In-Vitro Studies
- In-vitro Release Test (IVRT) &
In-Vitro Permeability Test (IVPT) - In-Vitro Binding Studies
- BCS Bio Waiver Studies
- In-Vitro Feeding Tube Studies
- Nail Permeation Studies
Special Studies
- Biosimilars & Large Molecules
- In Vivo Tape Stripping
- In Vivo Dermal Microdialysis
- Skin Blanching Studies
- Skin Irritation & Sensitization Test
- Glucose Clamp Studies
Clinical Trials
- Early Phase Clinical Trials
- Phase II-IV Clinical Trial & Post Marketing Studies
A Glimpse of The raptim experience
Complex Studies
On Healthy Vounteers
- Inhalation Products : Salmeterol + Fluticasone, Budesonide, Salbutamol, Glycopyrrolate, Beclomethasone MDI, Ipratropium Bromide MDI, Levalbuterol HFA Aerosol
- Narcotics & Psychotropic Substances : Morphine, Buprenorphine and Naloxone, Methylphenidate, Dexmethylphenidate & Pseudoephedrine products
- Hormonal Products : Fulvestrant Injection, Progesterone, Ethinyl Estradiol & Etonorgestral Vaginal Ring (Nuvaring), Levothyroxine & Dienogest
- Transdermal System : Buprenorphine & Naloxone, Nicotine, Estradiol, Fentanyl & Oxybutynin
- Vitamins : Phytonodione, Calcitriol, Ergocalciferol
Clinical End Point Studies
- On various indications such as Cancer (Ovarian Cancer, MBC, Lung Cancer, H&N, NSCLC, Prostate Cancer, Breast Cancer, Stomach cancer, Lymphoma) Acne Vulgaris, Schizophrenic, Epilepsy, HIV, Bipolar Disorder, COPD, Asthma etc
In-Vitro Studies
- In-vitro Release Testing (IVRT) for Topical Formulations : Acyclovir Ointment, Diclofenac Gel, Lidocaine Gel
- In-vitro Equilibrium and Kinetic Binding Study : Colesevelam Tablets/Suspension, Sevelamer Tablet, Sucroferric oxyhydroxide Tablet, Sucralfate suspension
- In-Vitro Permeation Testing (IVPT) for Topical Formulations using Human Cadaver Skin : Acyclovir Cream, Diclofenac Gel, Dapsone Gel
- Bio-waiver studies for BCS Class I drugs using Caco2 cell Lines : Buspirone (approved by USFDA on 3rd May 2018), Capecitabine, & Imatinib, Cyclophosphamide, Ramelteon, Varenicline & Vigabatrin Studies
Biosimilars & Large Molecules
- Validated methods for Teriparatide and Insulin Glargine (metabolites M1 and M2) from human plasma
- Method under development for Semaglutide and Liraglutide
- Preliminary work done on Octreotide and Adalimumab
facilities & infrastructure
State of the Art Infrastructure
~300
Beds
170 beds is Mumbai, Maharashtra and 122 beds in Gandhinagar, Gujarat
supported by
34
LCMS/MS, 3HPLC, 2 ICP
(LIMS, GLP compliant lab)
