Bioequivalence Studies
Enem’s expertise in Bioequivalence and bioanalysis services over the year has been extended to offer wide range of clinical research services. Our success is driven by our commitment to support customers with thorough understanding of the critical importance of the time, project management and GCP & GLP compliance.
Our strength is its team of ethical, experienced, knowledgeable, customer focussed professional.
Clinical Services
Facility
- Spacious clinical ward with an area of about 10,000 sq. ft.
- One fully equipped 2 beds ICU
- State-of-the-art two identical clinical wards of 36 beds each comprise total beds to 72
- Proximity to a hospital that will facilitate quicker and better handling of emergencies
- Pharmacy with controlled access
- Counseling room with audio-video recording facility
- Emergency calling point at bed and in wash room
- A recreational facility for subjects during the study
- Dedicated nurse/lab technician for samples withdrawal and care
- Volunteers’ data bank for recruitment of healthy human volunteers
- -800C deep freezers for plasma sample storage which are continuously monitored through data logging system
Expertise
- Can conduct the studies in different Therapeutic area like, lipid-lowering agents, anti-diabetics, antidepressants, Antibiotics, NSAID's, antiepileptic, muscle relaxant, cardiac drugs, Herbal and Nutraceuticals etc.
- Experienced in conduction of ‘Onco’ Products on healthy volunteers
- Experienced in conduction of ‘Cardiac Monitor’ study on healthy volunteers
- Studies perform on different formulations like, Tablet, Capsules, Syrups, Suspension, IV, Sprays etc.
- Can handle male and female volunteers study simultaneously
- Lead time to finalization of documents is very less
- Submission of reports in eCTD formats
Bioanalytical Services
Bioanalytical Lab offer comprehensive bioanalytical services for small molecule development including:
- Pharmacokinetic (PK) Analysis
- Bioavailability Studies
- Bioequivalence Studies
- Drug Interaction Studies
Our bioanalytical facility is well equipped with highly sophisticated instruments and multiple state-of-the-art resources, ensuring a straightforward and compliant submission for any country. The team comprises of well-trained and experienced scientists. Our comprehensive analytical SOPs ensure compliance with good laboratory practice (GLP) and current regulatory guidance documents.
Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:
- Extremely low LLOQ
- Wide linearity range
- Analysis of multiple drug/metabolites in single method
- Analysis from various biological matrices
- Quick method development
We can perform assays for over 150,000 samples per year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects.
Archival
Inhouse archival facility with about 1,500 sq. ft.
Our Strength
- State-of-the-art Infrastructure with the updated instruments in compliance with GxP norms to complete the project most efficiently and effectively with uncompromised quality.
- Dedicated R&D team with vivid experience in formulation development, analytical research, bioequivalence studies which understands your goals / Innovation / cost - effectiveness.
- Rapid turnaround time of each project with our technical expertise to save the time and cost.
- Ensures compliance as per requirements of Global regulatory agencies through our experience personnel.
- Customer satisfaction achieved through confidentiality, accountability, integrity, quality and speed in completing the projects.
