Bio & Pharm | GMP Compliance | CMC Development

King-Tech. & BIOPHA

One-stop GxP compliance services and green solvent-free process development for pharmaceutical facilities, quality systems, digital delivery, and the full drug development lifecycle.

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2011Founded in Zhuhai, Guangdong

30+Senior engineers and consultants

3 LocationsOffices in Zhuhai, Kunming, and Wuxi

NMPA / FDA / EMEAFor multiple regulatory systems

Professional Services

Compliance, engineering, and digital delivery services for pharmaceutical and related industries

We help clients build pharmaceutical facilities that meet the certification requirements of China NMPA, the U.S. FDA, the EU EMEA, and other relevant authorities, using science- and risk-based methods to support reliable delivery from planning and validation through sustained operation.

Service Fields

Our services cover pharmaceutical production, laboratories, extraction and purification, and digital systems, spanning facility construction, system go-live, quality systems, and green process development.

API

Engineering delivery, validation, quality systems, and data integrity for compliant production implementation.

Formulations

Support for formulation workshops, equipment systems, GMP project management, and computerized system validation.

Biologics

Focused on production facilities, critical systems, compliant digitalization, and validation delivery.

Laboratories

LIMS, data integrity, method validation, and laboratory quality management capability building.

Extraction & Purification

Combining green solvent-free processes, supercritical technology, and purification/crystallization platform capabilities.

Digital Systems

Covering pharmaceutical digital systems including MES, EBR, ERP, WMS, SCADA, and EMS.

About

About Us

Founded in 2011 and based in Zhuhai, Guangdong, King Tech has more than 30 senior engineers and consultants, with offices in Zhuhai, Kunming, and Wuxi.

We provide clients in pharmaceutical and related industries with consulting for digital engineering delivery, production information system solutions, computerized system validation, quality system development, GMP consulting and validation, project management, green process development, and drug development (CMC).

GMP Consulting & Validation QMS Development Data Integrity GAMP5 Validation

Capabilities

One-stop GMP compliance services based on science and risk management

We turn regulatory understanding, engineering experience, validation methods, and digital system delivery into executable project paths.

GMP Consulting & Validation

GMP gap analysis, GMP design review, validation master plans (VMP), system impact assessment, design qualification (DQ), risk management, and risk analysis.

Qualification & Validation

URS preparation, IQ/OQ/PQ, cleaning validation, process validation, method validation, and training.

Computerized System Validation

Based on the GAMP5 lifecycle approach, supporting go-live and compliant operation of MES, LIMS, WMS, SCADA, EMS, and related systems.

Quality System Development

Quality system improvement, SOP and management document drafting and review, personnel training, mock audits, and continual improvement.

Production Information System Solutions

Production information systems, pharmaceutical digitalization, smart manufacturing, and automation planning, with attention to network architecture, data backup, clock synchronization, and system integration.

Project Management & Digital Delivery

Consulting for digital engineering delivery, project management, deliverable planning, execution tracking, and knowledge capture.

Delivery Method

A clear path from requirements to delivery

Understand RequirementsAnalyze project characteristics, regulatory objectives, and business scope

Define ScopeBreak down tasks and plan deliverables and responsibility boundaries

System DesignDevelop quality, validation, data integrity, and digital system strategies

Implement ValidationComplete documentation, training, qualification, validation, and go-live support

Continual ImprovementOptimize systems through mock audits, data reviews, and operational feedback

Green Process & CMC

Green Solvent-free Process Development and Drug Development (CMC)

Based on supercritical, subcritical, solvent-free purification, and crystallization technologies, we provide green, safe, and reliable processing technology for plant-based raw materials, with products meeting GMP standards.

CMC Platform

Green Process Development and CMC Services

Core technologies include supercritical CO2 synthesis, extraction, chromatographic purification, crystallization, high-purity product preparation, and continuous crystallization.

Engineering

Modular System Manufacturing

Complete modular equipment for engineering delivery in pharmaceutical, chemical, and green process applications.

Pilot Base

Pilot and R&D Base

The Chuxiong, Yunnan R&D and production base supports full-process development and pilot production for extraction, purification, and crystallization, with analytical testing equipment.

Reports

Products and Test Reports

Product information and test data for high-purity CBD crystals, CBD oil, hydrogenated CBD, water-soluble CBD, functional co-crystal CBD, and related products.

Digital Platform