FACILITIES AND
INFRASTRUCTURE
Raptim has state-of-the-art facilities and infrastructure to facilitate quality execution of studies. The main components of infrastructure at Raptim are well equipped Clinical, Bio-analytical and In-vitro study setup. We have state-of-the-art equipment, regulatory compliant software, hardware and secured networks.
Raptim has a well-designed, custom-built, compliant facility to conduct various activities of Clinical Research in Mumbai and Gandhinagar. It is spread over a total floor area of 50,000 sq.ft. The area covers the Clinical Units, Analytical Laboratory area, Volunteer screening area, Volunteer Information centers and external archives.
Clinical Facilities
All the clinical activities are conducted in compliance with Global Regulatory Standards and the clinical unit meets world-class specifications.
Mumbai Clinical Facility
- Facility having more than 20,000 sq. ft. of carpet area
- We have a separate facility for volunteer screening
- 4 clinical units with 218 beds (including 12 beds in the Phase I unit) facilitating simultaneous conduction of multiple studies resulting in quick turnaround time
- 7 ECU (Emergency Care Unit) beds dedicated to managing adverse events
- Ease of conducting mix population studies with separate housing areas for Male and Female Subjects
- Clinical pathology lab accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) equipped to carry out tests for biochemistry, haematology, urine chemistry and serology as per study requirements
- The clinical facility has been approved by DCGI (INDIA), NABL and it is fully compliant with ICH GCP and other International Regulations like USFDA, WHO, UK MHRA, TGA, Canada, GCC, NPRA, Chile, HPRA, BfArM, etc
Gandhinagar Clinical Facility
- Started in the year 2018, it is located in the capital state of Gujarat (Gandhinagar) in India
- The clinical facility is located on a 27,702 sq. ft carpet area with state-of-the-art facility and access to 172 clinical beds divided into 3 clinical units
- Well-equipped Emergency care unit (ICU) – 2 beds
- Ease of conducting mix population studies with separate housing areas for Male and Female Subjects
- Temperature controlled pharmacy with secured access
- A highly skilled team of Principal Investigator, Pharmacists, Phlebotomists, CRAs, & QA personnel
- Recruitment with housing options available depending on the sponsor or study requirements
- Agreement with Clinical pathology labs accredited by the College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL), equipped to conduct tests for biochemistry, haematology, urine chemistry, and serology
Bio-Analytical Facility
We have a fully GLP-compliant analytical facility with state-of-the-art laboratories spread over 12,000 sq ft and managed by highly skilled and experienced scientific professionals and support personnel.
This team is competent to develop and validate a minimum of 4-6 methods every month. Thus, we have a faster turnaround time for developing the molecule as well as testing it.
State-of-the-art laboratory facilities for bio-analysis
Latest Instrumentation and technology to ensure project completion with quick-turnaround time
We offer – Electronic documentation (paperless) and are working on Scientific Data Management System (SDMS), Laboratory Information Management System (LIMS) and eLab (electronic Lab) notebook
Sample storage in controlled and limited access Deep freezer room with power back up and 24*7 temperature Monitoring and alarm system
Access controlled entry and exit facility
Separate sample processing laboratory
Validated and regulatory compliant software at Raptim Research ensures movement of data from the analytical lab to documentation within a CFR Part 11 compliant environment
Major equipment under annual maintenance contracts to minimize down time
One Stop Solution For Studies On Topical, Ophthalmic And Parenteral Products
In-vitro Studies
Independent setup to conduct In-vitro studies (IVRT/IVPT)
Equipped with 14 Franz diffusion cell consoles of Logan with auto-sampler
288 cells for multiple study conduct
+ 31– In-vitro Release Testing (IVRT) studies completed
+ 24– In-vitro Skin Permeation Testing (IVPT) studies completed
BCS Biowaiver Studies
Setup to conduct BCS biowaiver studies
20 model drug method validated
37 studies submitted for regulatory approvals, 13 studies approved by USFDA, 3 approved by other agencies.
Setup to conduct in vitro binding studies
10 studies submitted for regulatory approvals, 1 study approved by USFDA.
In-vitro Feeding Tube Studies
Separate set-up to conduct in vitro feeding tube studies
Experience with formulations of capsule pellets and oral suspensions
SALIENT POINTS
Independent regulatory-compliant facility for in-vitro dermal studies
Expanded the In-vitro facility by adding 14 Franz diffusion cell consoles of Logan with auto-sampler
288 cells for multiple study conduct • Only one lab with 05 IVPT approval
In vivo skin permeation – Dermal Microdialysis complete setup
In vivo skin permeation – Tape stripping complete setup
Vasoconstrictor assay (Skin Blanching) using Chromameter
Raptim Was Recently Inspected By USFDA, Focused On Raptim’s In-Vitro Quality Program, SOPs And Project History. The Inspection Was Concluded With No Observations (Zero 483)
Salient Features of Facilities
- Clinical Research facility with attached Analytical, Support, and Ancillary Function
- State-of-the-art Analytical, In-vitro study setup, and NABL Accredited clinical Lab
- Designated to International safety standard
- Access Control to all crucial labs to support confidentiality
- Ample storage facility for retaining samples at -20 ̊C and -70 ̊C
- Pool of latest and highly sensitive mass spectrophotometers and allied instruments
- Regulatory compliant archiving facility spread over 5,000 sq ft
- Systems with validated software that is CFR 21 Part 11 compliant