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
  • 3 clinical units with 170 beds facilitating simultaneous conduction of multiple studies resulting in quick turnaround time
  • Ease of conducting mix population studies with separate housing areas for Male and Female Subjects
  • Clinical pathology lab accredited by the College of American Pathologists (CAP) and 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) and it is fully compliant with ICH GCP and other International Regulations like USFDA, WHO, UK MHRA, TGA (Australia), Canada, 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 122 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

in-vitro study setup:

Raptim Research, a leader in In-vitro Release Testing (IVRT) and In-vitro Permeation Testing (IVPT) analytical method development, validation, and testing services, has continued to meet the fast-growing demand for these types of topical and transdermal drug analytical services with the most up to date regulatory requirement.

Through the use of appropriately selected In Vitro and In Vivo surrogate tests, we can accomplish the assessment of the BE of topical drug products. For most products IVRT, IVPT, and additional testing would be essential to establish BE along with Q1/Q2 testing.

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 11 Franz diffusion cell consoles of Logan with auto-sampler
  • 120 cells for multiple study conduct
  • + 20 – In-vitro Release Testing (IVRT) studies completed
  •  + 10 – In-vitro Skin Permeation Testing (IVPT) studies completed
BCS Biowaiver Studies
  • Setup to conduct BCS biowaiver studies
  • 20 model drug method validated
  • 7 studies submitted for regulatory approvals, 2 studies already approved
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 11 Franz diffusion cell consoles of Logan with auto-sampler
  • 120 cells for multiple study conduct
  • 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 Functions
  • 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