Our Expertise

Comprehensive CRO Services

An integrated portfolio of clinical research services — purpose-built for pharmaceutical and biopharmaceutical companies seeking reliable, compliance-driven support.

01 BA/BE Studies 02 Clinical Trials II–IV 03 Bioanalytical 04 PK/PD 05 Medical Writing 06 Pharmacovigilance 07 Analytical
BA/BE Studies
01

BA/BE Studies

Bioavailability & Bioequivalence — The Foundation of Generic Drug Development

Lazent Clinical delivers comprehensive BA/BE study services designed to satisfy the rigorous requirements of US FDA ANDA submissions and global regulatory filings. Our clinical pharmacology unit is equipped to conduct a wide spectrum of study designs under ICH E6(R2) GCP and 21 CFR Part 312 standards.

Key Capabilities

  • Single-dose and multiple-dose studies (fasting and fed conditions)
  • Crossover, parallel, replicate, and full replicate designs
  • Patient-centric BE studies for cytotoxic and psychotropic drugs
  • Special population studies: geriatric, post-menopausal women
  • Topical, transdermal patch, inhalation, and injectable studies
  • Clinical endpoint BE studies where conventional PK/PD methods are insufficient
  • Proof-of-concept and PD studies
  • Long housing and long washout study management
Clinical Trials Phase II-IV
02

Clinical Trials — Phase II to Phase IV

Comprehensive Trial Support from Proof-of-Concept to Post-Marketing

Lazent Clinical supports clinical development from Phase II proof-of-concept studies through large-scale Phase III pivotal trials and Phase IV post-marketing surveillance.

Key Capabilities

  • Phase II proof-of-concept and dose-ranging studies
  • Phase III pivotal confirmatory trials (IND/NCE)
  • Phase IV post-marketing and real-world evidence studies
  • Site selection, qualification, and regulatory assessment
  • Clinical operations, monitoring, and project management
  • Biostatistics, SAS programming, and CDISC-ready data packages
  • Clinical Data Management (EDC and paper-based)
Bioanalytical Services
03

Bioanalytical Services

GCLP-Compliant Quantitative Analysis with State-of-the-Art LC-MS/MS

Our bioanalytical laboratory is purpose-built for precision. Equipped with high-sensitivity LC-MS/MS systems and operated under GCLP compliance, we deliver fully validated, regulatory-grade bioanalytical data for submission to US FDA, EMA, and other global agencies.

Key Capabilities

  • Bioanalytical method development and full validation (FDA/EMA guidelines)
  • Quantitative analysis in plasma, serum, whole blood, urine, and tissue matrices
  • Small molecule and complex molecule assays
  • Hormones, steroids, and endogenous molecule quantification
  • Nitrosamine and genotoxic impurity analysis using LC-MS/MS
  • Elemental analysis by ICP-MS
  • Biosimilar and immunogenicity assays
  • Full sample management with chain-of-custody documentation
PK/PD Studies
04

Pharmacokinetics / Pharmacodynamics (PK/PD)

Translating Data into Drug Development Decisions

Pharmacokinetic and pharmacodynamic studies are the scientific backbone of drug development decisions. Lazent Clinical's PK/PD team designs and executes studies that generate critical data for dose selection, drug-drug interaction assessment, and regulatory submissions.

Key Capabilities

  • Single and multiple-dose PK studies
  • Food effect and drug-drug interaction studies
  • PK/PD modeling and simulation
  • Non-compartmental analysis using Phoenix WinNonLin
  • Population PK analysis
  • Tissue distribution and excretion studies
  • Pediatric and special population PK studies
Medical Writing
05

Medical Writing & Regulatory Affairs

Precision Writing. Global Submission Readiness.

Regulatory success depends as much on how data is communicated as on the data itself. Our dedicated medical writing team produces clear, scientifically rigorous documents that withstand review by the world's most demanding regulatory agencies.

Key Capabilities

  • Clinical Study Protocols and amendments
  • Investigator Brochures (IB) and Informed Consent Forms (ICF)
  • Clinical Study Reports (CSR) — ICH E3 compliant
  • ANDA/NDA/IND dossier preparation and review
  • Integrated Summaries of Safety and Efficacy (ISS/ISE)
  • Regulatory strategy consulting for FDA, EMA, DCGI, and global agencies
  • Response preparation for regulatory queries and deficiency letters
Pharmacovigilance
06

Pharmacovigilance Services

Drug Safety — From First Dose to Lifecycle Management

Patient safety is non-negotiable. Lazent Clinical provides a comprehensive pharmacovigilance program covering the entire drug lifecycle — from IND-stage safety monitoring through post-market surveillance — ensuring sponsors remain compliant with evolving global safety reporting requirements.

Key Capabilities

  • Individual Case Safety Report (ICSR) processing and expedited reporting
  • MedWatch submissions to US FDA
  • Periodic Safety Update Reports (PSURs / PBRERs)
  • Risk Management Plan (RMP) preparation and maintenance
  • Signal detection, trend analysis, and benefit-risk evaluation
  • Literature screening and safety surveillance
  • Post-marketing surveillance study design and execution
Analytical Services
07

Analytical Services

Comprehensive Analytical Testing for Drug Substance & Drug Product

Beyond bioanalysis, Lazent Clinical offers a full range of analytical testing services supporting pharmaceutical development, quality control, and regulatory submissions for drug substances and finished dosage forms.

Key Capabilities

  • Method development and validation for drug substance and drug product
  • Stability studies (ICH Q1A — accelerated, intermediate, long-term)
  • In-vitro dissolution testing and IVIVC studies
  • Impurity profiling and degradation product analysis
  • Forced degradation (stress testing) studies
  • Formulation compatibility and excipient interaction studies
  • Analytical support for ANDA / CTD Module 3 sections

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