End-to-End CDMO
Excellence
Comprehensive contract development and manufacturing services from Pre-IND to commercial launch.
CDMO Excellence
Formulation Development
Expert pharmaceutical formulation
Clinical Trial Materials
Phase I-III trial support
Commercial Manufacturing
Scalable production solutions
Comprehensive CDMO Services
SGP Care's Contract Development and Manufacturing Organization services provide end-to-end support for pharmaceutical companies, biotechnology firms, and research institutions. From initial formulation development through commercial manufacturing, we deliver quality, compliance, and innovation at every stage.
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) is a company that provides comprehensive services from drug development through drug manufacturing. Unlike traditional Contract Manufacturing Organizations (CMOs) that focus solely on production, CDMOs offer integrated development and manufacturing solutions.
Development Services
Formulation development, analytical method development, and process optimization
Manufacturing Services
Clinical trial materials, commercial production, and packaging solutions
Regulatory Support
FDA submissions, compliance documentation, and inspection preparation
Why Partner with SGP Care's CDMO Services?
Accelerated Time-to-Market
Streamlined development processes and parallel activities reduce overall project timelines, getting your products to market faster.
Cost Efficiency
Eliminate capital investments in facilities and equipment while accessing specialized expertise and established infrastructure.
Expert Team
Access to experienced scientists, regulatory experts, and manufacturing professionals with proven track records.
Comprehensive CDMO Service Portfolio
From concept to commercialization, our integrated CDMO services support every phase of pharmaceutical development and manufacturing.
Development Services
Formulation Development
Expert formulation scientists develop optimal drug formulations to enhance bioavailability, stability, and patient compliance. Our comprehensive approach includes preformulation studies, prototype development, and optimization.
- Preformulation characterization and compatibility studies
- Oral solid dosage form development (tablets, capsules)
- Liquid formulation development (solutions, suspensions)
- Topical and transdermal formulation development
- Controlled and sustained release formulations
- Stability testing and shelf-life determination
Analytical Method Development
Development and validation of analytical methods to support formulation development, quality control, and regulatory submissions. Our analytical capabilities ensure product quality and regulatory compliance.
- HPLC/UPLC method development and validation
- Mass spectrometry (LC-MS/MS) methods
- Dissolution testing and method development
- Impurity identification and quantification
- Bioanalytical method development
- Method transfer and technology transfer
Manufacturing Services
Clinical Trial Material Supply
Reliable supply of clinical trial materials from Phase I through Phase III studies. Our cGMP-compliant manufacturing ensures product quality and regulatory compliance for successful clinical programs.
- Phase I through Phase III material production
- Small batch and pilot scale manufacturing
- Placebo and comparator drug manufacturing
- Clinical packaging and labeling services
- Global distribution and logistics support
- Emergency supply and expedited production
Commercial Manufacturing
Scalable commercial manufacturing solutions for post-approval drug products. Our state-of-the-art facilities and quality systems ensure consistent, high-quality production for market supply.
- Large-scale commercial production capabilities
- Multi-product manufacturing flexibility
- Capacity planning and demand forecasting
- Supply chain optimization and management
- Continuous improvement and cost optimization
- Technology transfer from development to commercial
Specialized CDMO Services
Technology Transfer
Seamless transfer of processes from research and development to commercial manufacturing, ensuring product quality and regulatory compliance.
- Process documentation and knowledge transfer
- Equipment qualification and validation
- Process validation and optimization
- Method transfer and validation
Scale-Up Services
Expert scale-up from laboratory to pilot to commercial scale, maintaining product quality and process efficiency throughout the scaling process.
- Process scale-up studies and optimization
- Equipment selection and design
- Risk assessment and mitigation strategies
- Process modeling and simulation
Packaging & Labeling
Comprehensive packaging and labeling services for clinical and commercial products, ensuring compliance with global regulatory requirements.
- Primary and secondary packaging solutions
- Clinical trial packaging and labeling
- Commercial packaging design and execution
- Serialization and track-and-trace compliance
End-to-End CDMO Process
Our comprehensive CDMO process takes your pharmaceutical project from initial concept through commercial launch, ensuring quality, compliance, and efficiency at every stage.
Phase 1: Project Assessment & Planning
Comprehensive evaluation of your project requirements, regulatory pathway, and development strategy. We work with you to create a detailed project plan and timeline.
- • Initial project consultation and feasibility assessment
- • Regulatory pathway analysis and planning
- • Resource allocation and timeline development
- • Risk assessment and mitigation strategies
Phase 2: Formulation Development
Development of optimal drug formulations through systematic screening, optimization, and characterization studies to ensure product quality and performance.
- • Preformulation studies and API characterization
- • Formulation screening and optimization
- • Analytical method development and validation
- • Stability testing and shelf-life determination
Phase 3: Process Development & Scale-Up
Development and optimization of manufacturing processes from laboratory scale to commercial production, ensuring scalability and reproducibility.
- • Process development and optimization studies
- • Scale-up from lab to pilot to commercial scale
- • Process validation and documentation
- • Equipment qualification and facility preparation
Phase 4: Clinical Trial Material Production
Manufacturing of clinical trial materials under cGMP conditions to support your clinical development program from Phase I through Phase III.
- • Clinical batch manufacturing and release
- • Packaging and labeling for clinical trials
- • Distribution and logistics coordination
- • Regulatory documentation and support
Phase 5: Regulatory Support & Submissions
Comprehensive regulatory support for IND, NDA, and other regulatory submissions, ensuring compliance with FDA and international requirements.
- • Regulatory dossier preparation and submission
- • CMC section development and documentation
- • Regulatory agency interaction and communication
- • Inspection preparation and support
Phase 6: Commercial Manufacturing
Transition to commercial manufacturing with scalable production capabilities, quality assurance, and supply chain management for market success.
- • Commercial-scale manufacturing and supply
- • Quality control and release testing
- • Supply chain optimization and management
- • Continuous improvement and lifecycle management
State-of-the-Art CDMO Capabilities
Our advanced facilities, equipment, and expertise enable us to handle diverse pharmaceutical development and manufacturing projects with the highest standards of quality and compliance.
Advanced Manufacturing Facilities
Our cGMP-compliant facilities feature the latest technology and equipment to support pharmaceutical development and manufacturing from early-stage development through commercial production.
- ISO Class 7 and 8 cleanroom environments for sterile manufacturing
- Automated manufacturing lines with advanced process control
- Flexible manufacturing suites for multi-product capabilities
- Comprehensive quality control laboratories
- Temperature-controlled storage and distribution facilities
Technical Capabilities & Equipment
Solid Dosage Manufacturing
- • High-speed tablet presses
- • Capsule filling equipment
- • Coating systems
- • Granulation equipment
- • Blending and mixing systems
Liquid Manufacturing
- • Sterile filling systems
- • Aseptic processing capabilities
- • Liquid mixing and compounding
- • Vial and ampoule filling lines
- • Lyophilization equipment
Analytical Capabilities
- • HPLC/UPLC systems
- • Mass spectrometry (LC-MS/MS)
- • Dissolution testing equipment
- • Microbiology testing facilities
- • Stability testing chambers
Quality Management System
Our comprehensive quality management system ensures product quality, regulatory compliance, and continuous improvement throughout all CDMO operations.
- ISO 9001:2015 certified quality system
- cGMP compliance and documentation
- Change control and deviation management
- Supplier qualification and management
- Continuous improvement programs
Regulatory Expertise
Our regulatory team provides expert guidance and support for global regulatory submissions and compliance requirements across all major markets.
- FDA, EMA, and international regulatory expertise
- IND, NDA, and ANDA submission support
- Regulatory strategy development
- Inspection preparation and support
- Global market access strategies
Client Success Stories
Our CDMO partnerships have enabled pharmaceutical companies to successfully bring innovative therapies to market
Dr. David Rodriguez
VP of Manufacturing, BioPharma Solutions Inc.
"SGP Care's CDMO services were instrumental in the successful launch of our novel oncology therapy. Their expertise in formulation development and regulatory support accelerated our timeline by 18 months and ensured FDA approval on the first submission."
Maria Johnson
Chief Development Officer, Therapeutic Innovations Ltd.
"The seamless technology transfer and scale-up services provided by SGP Care enabled us to transition from clinical trials to commercial manufacturing without any delays. Their quality systems and regulatory compliance are exemplary."
Ready to Start Your CDMO Partnership?
Contact our CDMO experts to discuss your pharmaceutical development and manufacturing needs. We're ready to support your project from concept to commercialization.
Contact Our CDMO Team
777 S. Flagler Dr.
Suite 800 - West Tower
Palm Beach, FL 33401
CDMO Services Hours
Monday - Friday: 7:00 AM - 7:00 PM EST
Saturday: 9:00 AM - 3:00 PM EST
24/7 Emergency Project Support
Request CDMO Consultation
CDMO Services FAQ
Frequently asked questions about our contract development and manufacturing services