Enhance your drug development journey with our BA/BE solutions.
We at Aizant offer a wide range of bioavailability (BA) and bioequivalence (BE) services that meet global regulatory standards. Our flexible solutions and experts provide fast-track approval for generics and new formulations by combining deep scientific expertise with regulatory knowledge to accelerate market entry.
Clinical
We specialize in clinical BA/BE studies to confirm that drug is comparable in safety and efficacy to the reference product.
- Conducting pharmacokinetic (PK) studies in healthy volunteers.
- Assessing the impact of food, age, and gender on drug absorption and metabolism.
- Performing studies on diverse populations, including male/female subjects and pre/post-menopausal women.
- Optimizing dosing for safety and efficacy through studies.
- Single/Multiple ascending dose studies.
- 505(b)(2) studies for regulatory submissions.
- Formulation studies on various dosage forms.
- Drug-drug interactive studies.
- Patient based BA/BE studies.
- Focusing on digitization & aiming for paperless execution of studies using electronic data capture (EDC) in the near future.
Pharmacokinetics (PK), Pharmacodynamics (PD), and Biostatistics
Our team of PK/PD experts and biostatisticians confirms that every study design meet the global standards and regulatory guidelines.
- Custom study protocols with sample size calculations.
- Advanced statistical analysis using tools.
- Evaluating treatment responses in different populations.
- Clinical endpoint studies to assess the relationship between drug concentration and its pharmacological effects.
- Preparation of clinical study reports for regulatory submissions to agencies like FDA and EMA.
- Creation of CDISC datasets for seamless regulatory filings.
- Providing Insights into predictability of biostudies(Bio Success Rate) using advanced modulation & simulation tools.
Medical Writing
Aizant’s medical writing team specializes in drafting key clinical documents quickly and efficiently.
- Protocol drafting with timely preparation of clinical protocols.
- Feasibility assessment with evaluations to determine study viability.
- Study documentation including preparation of CRFs, pre-study documents, and study execution plans.
- Clinical study reports that are regulatory-compliant to support submissions.
Project Management Services
The project management team facilitates seamless study execution from start to finish.
- End-to-end management with support from feasibility assessment to final study report.
- Timeline management with communication and monitoring of project milestones.
- Single point of contact (SPOC) supporting smooth communication and efficient project flow.
