We maintain comprehensive equipment across R&D, analytical, and manufacturing functions to support projects from discovery through commercial production.

Synthesis equipment:

• Lab reactors: Round-bottom flasks to 20L jacketed reactors
• Pilot reactors: 5L, 20L, 50L, 100L glass-lined and stainless
• Commercial reactors: 200L, 500L, 1000L+ capacity
• Automated parallel synthesis (24, 48, 96-well formats)
• Microwave synthesis reactors
• Flow chemistry systems for continuous processing
• High-pressure hydrogenation reactors
• Cryogenic capabilities (-78°C to 200°C)

Analytical instrumentation:

• NMR: 200 MHz, 400 MHz, 600 MHz (with cryoprobe)
• Mass spectrometry: LC-MS, GC-MS, LC-MS/MS, HRMS
• Chromatography: HPLC, UPLC, GC with multiple detectors
• Spectroscopy: FT-IR, UV-Vis, fluorescence, Raman
• Thermal analysis: DSC, TGA, DTA
• Particle characterization: laser diffraction, SEM

Processing equipment:

• Filtration: Nutsche filters, centrifuges, filter presses
• Drying: Vacuum ovens, fluid bed dryers, spray dryers
• Purification: Prep HPLC, flash chromatography
• Milling: Jet mills, hammer mills, ball mills

Our global partnership network spans three continents, providing access to specialized capabilities, regional expertise, and cost-effective manufacturing options.

United States:

• ChemContract headquarters: Huntington Beach, California (FDA-registered)
• cGMP manufacturing facility with full analytical capabilities
• Access to US suppliers and regulatory expertise
• Direct service to North American clients

European Union:

• Partner facilities in Western Europe (Germany, Switzerland, UK)
• EMA-approved manufacturing sites
• Specialized chemistry capabilities (chiral, organometallic)
• EU regulatory expertise and documentation

India:

• Multiple ISO and cGMP-certified partner facilities
• Cost-effective large-scale manufacturing
• Specialized process chemistry expertise
• Access to unique starting materials and intermediates

All partners are carefully vetted, audited, and maintain quality systems compatible with FDA, EMA, and ICH requirements.

Our facilities and partner network maintain comprehensive certifications ensuring quality, safety, and regulatory compliance.

Quality management certifications:

• ISO 9001:2015 - Quality Management Systems
• ISO 14001:2015 - Environmental Management (select facilities)
• ISO 45001:2018 - Occupational Health & Safety (select facilities)

Pharmaceutical certifications:

• FDA Registration - US facility registered with FDA
• cGMP Compliance - Per 21 CFR Parts 210 & 211
• EMA Certification - European partner facilities
• WHO GMP - Select manufacturing partners

Specialty certifications:

• DEA Registration - For controlled substance handling
• Kosher & Halal Certification - Available through partners
• Non-GMO Certification - For applicable products

We maintain current certification documents and welcome audits from clients and regulatory agencies.

Partner selection follows a rigorous qualification process ensuring technical capability, quality systems, and regulatory compliance.

Partner qualification process:

• Initial screening:Capabilities assessment, certifications review, references
• Technical evaluation:Equipment, expertise, capacity, analytical capabilities
• Quality audit:On-site inspection of facilities, systems, and documentation
• Trial project:Small-scale project to validate capabilities
• Approval:Addition to approved supplier list with annual re-qualification

Ongoing oversight:

• Annual audits of all active partners
• Quality agreements and KPI monitoring
• Regular technical exchanges and training
• Deviation and CAPA tracking
• Continuous improvement initiatives

We maintain direct relationships with all partners and personally oversee all projects to ensure quality and compliance.

Our global partnership network provides unique advantages compared to single-site contract manufacturers.

Technical advantages:

• Specialized expertise:Access to unique chemistry capabilities across partners
• Expanded capacity:Flexible scale from mg to metric tons
• Technology diversity:Multiple approaches to challenging chemistry
• Risk mitigation:Backup capacity if issues arise at one site

Commercial advantages:

• Cost optimization:Leverage regional cost advantages (labor, materials)
• Speed to market:Parallel execution across multiple sites
• Regulatory flexibility:Choose manufacturing location based on target markets
• Supply security:Multiple sources for business continuity

Strategic advantages:

• Single point of contact for global projects
• Unified quality standards across network
• Coordinated logistics and documentation
• Long-term partnership approach

Yes, our network includes partners with specialized equipment for challenging chemistries and unique processing requirements.

Specialized synthesis capabilities:

• High-pressure chemistry:Hydrogenations up to 100 bar
• Cryogenic reactions:Down to -100°C
• High-temperature processes:Up to 300°C in specialized reactors
• Photochemistry:UV reactors for photochemical transformations
• Electrochemistry:Electrochemical synthesis capabilities
• Flow chemistry:Continuous processing for hazardous reactions

Specialized processing:

• Spray drying for particle engineering
• Supercritical fluid extraction and processing
• Continuous crystallization systems
• Controlled atmosphere processing (oxygen-free, moisture-free)
• Clean room manufacturing (Class 100K to 100)
• Sterile manufacturing (aseptic processing)

If we don't have specific capabilities in-house, we can quickly identify qualified partners from our network or develop new partnerships as needed.

We serve as the central coordination point for all multi-site projects, ensuring seamless execution and consistent quality.

Project management approach:

• Single point of contact:Dedicated project manager coordinates all activities
• Unified timeline:Integrated project schedule across all sites
• Quality oversight:ChemContract QA reviews all work regardless of location
• Technical coordination:Our scientists provide technical direction to partners
• Regular updates:Weekly status reports and monthly detailed reviews

Quality assurance:

• Unified specifications and acceptance criteria
• Standardized analytical methods across sites
• Central review of all batch records and COAs
• Cross-site comparability studies
• Consolidated regulatory documentation

Logistics management:

• Coordinated material transfers between sites
• Consolidated shipping to minimize costs
• Complete chain of custody documentation
• Temperature-controlled transport when needed

Our analytical laboratories are equipped with comprehensive instrumentation for complete compound characterization and quality control.

Spectroscopic techniques:

• NMR:200 MHz, 400 MHz, 600 MHz instruments
• 1D experiments: 1H, 13C, 19F, 31P, DEPT
• 2D experiments: COSY, HSQC, HMBC, NOESY, ROESY
• Variable temperature and solvent suppression
• FT-IR:Solid, liquid, and ATR sampling
• UV-Vis:Absorption and dissolution testing
• Raman:Available through partners

Chromatography & mass spectrometry:

• HPLC/UPLC:Multiple systems with UV, PDA, ELSD, CAD detection
• GC:FID, TCD, ECD detection
• LC-MS:Single quad and triple quad systems
• GC-MS:Single quad and triple quad systems
• HRMS:Time-of-flight for accurate mass
• Prep HPLC:Purification and fraction collection

Physical characterization:

• DSC/TGA for thermal properties
• Karl Fischer titration for water content
• Particle size analyzers (laser diffraction)
• Dissolution apparatus (USP I-IV)
• Optical rotation (polarimetry)
• X-ray diffraction (XRD) for polymorphism

Yes, we continuously invest in new equipment and technologies to maintain cutting-edge capabilities and serve evolving client needs.

Recent investments:

• UPLC-MS/MS system for high-sensitivity analysis
• 600 MHz NMR with cryoprobe for complex structure elucidation
• Automated parallel synthesis platform (96-well)
• Flow chemistry reactor for continuous processing
• Particle size analyzer with morphology imaging

Planned upgrades:

• Additional cGMP manufacturing capacity (500L reactor)
• Expanded analytical capabilities (ICP-MS for metals)
• Process analytical technology (PAT) tools
• Laboratory information management system (LIMS) upgrade

Technology partnerships:

• Collaboration with equipment vendors for beta testing
• Access to specialized equipment through university partnerships
• Sharing of capabilities across global network

We evaluate new technologies based on client needs and industry trends, investing strategically to provide competitive advantages.

All equipment is properly qualified and maintained on regular calibration schedules to ensure reliable performance and regulatory compliance.

Equipment qualification:

• IQ (Installation Qualification):Verification of proper installation
• OQ (Operational Qualification):Verification equipment operates per specifications
• PQ (Performance Qualification):Verification of performance in actual use
• Complete qualification documentation for GMP equipment
• Requalification after major service or relocation

Calibration program:

• Annual calibration for all critical instruments
• Quarterly or monthly calibration for high-use equipment
• NIST-traceable standards for all calibrations
• Calibration certificates maintained in equipment files
• Out-of-calibration investigations and impact assessments

Preventive maintenance:

• Scheduled maintenance per manufacturer recommendations
• Preventive maintenance logs and service records
• Spare parts inventory for critical equipment
• Vendor service contracts for major instruments

Absolutely. We welcome client site visits and are accustomed to hosting inspections from clients, regulatory agencies, and auditors.

Site visit options:

• Facility tours:General overview of capabilities and equipment
• Technical meetings:Detailed discussions with scientists and engineers
• Project reviews:In-person review of ongoing projects
• Quality audits:Comprehensive review of quality systems and documentation
• Equipment demonstrations:Hands-on demonstrations of capabilities

Preparation for visits:

• Advanced scheduling to ensure key personnel available
• Customized agendas based on client interests
• Safety briefings and required PPE provided
• Conference room facilities for meetings
• Accommodations assistance if needed

Regulatory inspections:

• FDA inspection readiness maintained at all times
• Experience hosting FDA, EMA, and other regulatory inspections
• Dedicated inspection response team
• Complete documentation readily accessible

Contact us to schedule a site visit or virtual tour of our facilities.

Safety is our top priority. We maintain comprehensive safety programs, engineering controls, and emergency response capabilities.

Safety infrastructure:

• Fume hoods and local exhaust ventilation
• Safety showers and eyewash stations
• Fire suppression systems (sprinklers, CO2, FM200)
• Gas detection and monitoring systems
• Explosion-proof equipment in hazardous areas
• Backup power systems (UPS, generators)

Safety programs:

• Training:Comprehensive safety training for all personnel
• PPE:Required personal protective equipment based on hazards
• SOPs:Detailed safety procedures for all operations
• Hazard analysis:Process hazard analysis (PHA) for all reactions
• Incident reporting:Near-miss and incident tracking with root cause analysis
• Emergency response:Trained first responders and emergency drills

Regulatory compliance:

• OSHA compliance and regular inspections
• EPA environmental compliance
• DOT hazmat shipping certification
• Waste disposal through licensed contractors

Our global network provides multiple layers of risk mitigation compared to working with a single contract manufacturer.

Technical risk mitigation:

• Multiple options:If one site can't handle specific chemistry, we have alternatives
• Technology backup:Multiple approaches to challenging transformations
• Analytical verification:Independent testing across multiple labs
• Process troubleshooting:Access to diverse expertise for problem-solving

Supply chain risk mitigation:

• Geographic diversification:Not dependent on single location
• Dual sourcing:Option to manufacture at multiple sites
• Material availability:Access to different supplier bases
• Capacity flexibility:Can shift production if capacity issues arise

Business continuity:

• Backup manufacturing sites for critical products
• Technology transfer capabilities between sites
• Inventory management across network
• Business interruption insurance coverage

Quality assurance:

• Central quality oversight regardless of manufacturing site
• Unified specifications and acceptance criteria
• Cross-site comparability and validation
• Independent quality review before release

IP protection is critical when working across multiple sites. We implement comprehensive safeguards to protect your confidential information.

Legal protections:

• Direct NDAs:ChemContract executes NDA with you
• Subcontractor NDAs:All partners bound by confidentiality agreements
• Quality agreements:Define IP ownership and confidentiality obligations
• Manufacturing agreements:Clear terms regarding IP rights and usage

Operational controls:

• Need-to-know access to sensitive information
• Code names for confidential projects
• Secure electronic data transmission (encrypted)
• Physical security at all partner sites
• Document control and retention policies

IP ownership:

• Client retains all IP rights to their compounds and processes
• Work-for-hire arrangements standard
• Clear documentation of invention ownership
• Option for joint development agreements if desired

We have 25+ years of experience protecting client IP with zero breaches. Your confidential information is safe across our global network.

Leveraging our global network is simple - we handle all the complexity and coordination behind the scenes.

The process:

• Step 1:Describe your project requirements to ChemContract
• Step 2:We evaluate which facilities in our network are best suited
• Step 3:We provide unified proposal with timeline and pricing
• Step 4:Single contract with ChemContract (we manage subcontractors)
• Step 5:We coordinate all work across sites
• Step 6:You receive consolidated deliverables and documentation

Your advantages:

• Single point of contact for entire project
• Access to best capabilities regardless of location
• Optimized cost through strategic site selection
• ChemContract quality oversight throughout
• Consolidated documentation and logistics
• One invoice, one relationship

Transparency:

• We disclose which facilities are performing work
• Client site visits welcome at any partner facility
• Direct technical communication with partner scientists if desired
• Full traceability of materials and documentation

Contact us today:
Phone: +1 (714) 732-8549
Email: [email protected]

Let us show you how our global network can accelerate your project while reducing costs and risks.