Bio-innova offers a wide range of professional services
from clinical research, pharmacokinetics, bioavailability,
bioequivalence, bioanalysis, and statistics to data
management. Our scientific experts and quality
assurance teams are committed to serve our client’s
needs in the fields of pharmaceutical, biotechnology,
food and medical devices. We value close collaborative
partnership, and assist our clients to control costs,
accelerate time-to-market, minimize risks and maximize
return on investment.
“YOUR EXPERT PARTNER PROVIDING HIGH QUALITY
SPEED AND COST EFFECTIVENESS”
– Pilot and Pivotal Bioequivalence
– Bioavailability
– Phase 1-IV Clinical Trials
– Pharmacokinetics
– Pharmacodynamics
– Abbreviated New Drug Application(ANDA)
– Dermatopharmacokinetics
– Food interaction
– Drug interaction
– Evaluation of drug delivery system
– Cosmetic Trials
– Herbal Trials
– Regulatory affairs
Our services:
– Protocol development
– Regulatory approval
– Ethics Committee approval
– Study population
– Clinical study
– Analytical method development and validation
– Bioanalysis
– Data management and Statistics
– Report writing and submission
– Quality assurance
Our modern in-house 60 beds are available for early clinical trials, bioavailability, and bioequivalence studies with special care and treatment from our well-trained medical professionals. We serve our clients with a state-of-the-art, well-equipped clinical research facilities with adequate recreation, dining, and entertaining functions for volunteers
We, Bio-innova, have developed and validated methods according to US-FDA and EMA guidelines for various drugs using such high technology and validated equipments as UPLC/MS/MS (Acquity UPLC waters system/ Quattro premier system, Micromass) and HPLC (UV-visible, Photo diode array and Fluorescence Detecting). Our hardware and software are 21 CFR Part 11 compliance.