Comprehensive Process Development for Scalable Pharmaceutical Manufacturing
At Vista Biologicals, we deliver comprehensive regulatory and compliance solutions designed to accelerate advanced pharmaceutical manufacturing and services. Our expertise helps ensure your active pharmaceutical ingredients (APIs) and biologics are developed, documented, and produced to meet U.S. FDA cGMP standards, supporting your successful regulatory outcomes.
We assist clients with preparing regulatory-ready documentation – such as the Chemistry, Manufacturing, and Controls (CMC) section for IND filings – and responding to agency questions throughout the review process. We support full process validation, analytical method validation, and stability programs in anticipation of clinical or commercial supply.
Key Regulatory Support Capabilities
- Quality Control and Release Testing
Our laboratory performs testing of cell banks, raw materials, and reference standards, as well as in-process, intermediate, and final product release testing for both bulk drug substance and finished drug product. - Analytical Methods and Validation
We implement and validate analytical methods, monitor critical utilities such as high-purity water, clean steam, and compressed air, and handle process and cleaning-validation samples. - Stability Programs and Regulatory Compliance
We design and operate ICH-compliant stability programs for intermediates, bulk drug substance, drug product, and placebo, and support regulatory submission and inspection strategies.
Why Partner with Vista Biologicals
Choosing Vista Biologicals means aligning with a partner whose infrastructure and expertise are grounded in both pharmaceutical services and full-scale pharmaceutical manufacturing.
- Decades of experience supporting biotechnology and biopharmaceutical clients through regulatory pathways, process validation, and GMP production readiness.
- Facilities and operational controls are designed for compliance, ensuring smooth transitions from development to regulated manufacturing.
- Customized workflows – from IND-stage CMC packages to method validations and commercial-scale production readiness – delivered with precision and responsiveness.
Whether your need is for IND or CMC preparation, method validation, stability studies, or full regulatory readiness for GMP manufacturing, Vista Biologicals stands ready to support your path from documentation through production.
