Welcome to Zest Business Solutions LLC

At Zest Business Solutions LLC, we are dedicated to empowering the pharmaceutical and biotechnology industries through specialized clinical data, statistical programming, pharmacokinetic (PK) and consulting services.

Our mission is to bridge science and technology by delivering accurate, efficient, and regulatory-compliant data solutions that enable confident decision-making and smooth regulatory submissions.

From first-in-human trials to pivotal Phase III studies, Zest provides comprehensive support at every stage of the clinical development lifecycle. We combine technical precision, regulatory insight, and operational flexibility to meet the complex demands of modern drug development.

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About Us

Zest Business Solutions LLC, based in Maryland, USA, is a team of experienced clinical data professionals with deep expertise in biostatistics, CDISC implementation, SAS programming and pharmacokinetic analysis.


Our leadership brings years of hands-on experience supporting regulatory submissions to the FDA, EMA, and other global authorities. We pride ourselves on our ability to transform raw clinical data into submission-ready packages that are accurate, traceable, and fully compliant with CDISC and ICH guidelines.

Quality

Delivering outputs that are accurate, validated, and fully traceable from source to submission.

Compliance

Adhering to FDA, EMA, CDISC, ICH E3/E9, and 21 CFR Part 11 standards.

Efficiency

Leveraging automation, streamlined workflows, and standardized processes to reduce turnaround time without compromising quality.

Our goal is simple yet powerful: To deliver reliable, timely, and compliant data solutions that help sponsors bring safe and effective therapies to patients faster.

Our Services

Zest offers a full spectrum of data management, statistical programming, and pharmacokinetic (PK) analysis services, designed to integrate seamlessly with sponsor and CRO operations.

CDISC Package Development

  • Development and validation of SDTM and ADaM datasets following the latest CDISC standards
  • Pinnacle 21 validation, data conformance review, and issue resolution
  • Creation of Define.xml files, Reviewer's Guides, and Data Definition documentation
  • Preparation of submission-ready data packages aligned with FDA and EMA expectations

Statistical Programming

  • Programming of Tables, Listings, and Figures (TLFs) for clinical study reports (CSRs)
  • Development of interim and final analysis datasets for biostatistical evaluation
  • Independent QC validation of datasets and programs to ensure accuracy and reproducibility
  • Creation of custom SAS macros and automation tools for efficiency and consistency across deliverables

Pharmacokinetic (PK) Support

  • Execution of Non-Compartmental Analysis (NCA) using Phoenix WinNonlin or SAS
  • Development of CDISC ADaM-compliant PK datasets for integrated analyses
  • Production of PK summary tables, concentration-time plots, and parameter listings
  • Preparation of regulatory-compliant PK reports suitable for clinical and bioequivalence studies

Drug Development Consulting

  • Biopharmaceutical consulting and formulation guidance
  • Clinical data strategy and submission planning
  • Bridging science, data, and regulatory expectations
  • Helping sponsors optimize development timelines and submission readiness

Why Partner with Zest?

End-to-End Expertise

Seamless integration from raw data through final submission deliverables.

Experienced Team

Senior professionals with deep domain expertise in programming, biostatistics, and PK analysis.

Scalable Delivery Model

Flexible resource models for single studies or multi-program portfolios.

Regulatory Confidence

Proven compliance with CDISC, FDA, EMA, and ICH submission requirements.

Commitment to Quality

Rigorous QC, traceability, and adherence to GxP and 21 CFR Part 11 practices.

At Zest, we don't just generate datasets and outputs. We deliver confidence, compliance, and clarity in your clinical data.

Contact Us

Ready to discuss your project or request a quote? We'd love to hear from you.

Location
Maryland, USA

We'll get back to you within 1–2 business days.