Your Trusted
CDMO Partner
Accelerate your pharmaceutical development with our comprehensive contract development and manufacturing services. From Pre-IND to commercial launch, we provide the expertise and infrastructure pharmaceutical companies need to succeed.
CDMO Outsourcing Growth
Cost Reduction Potential
Time to Market
Pharmaceutical Industry Challenges
Understanding the complex challenges facing pharmaceutical companies today and how strategic outsourcing partnerships can provide solutions.
Rising Development Costs
Pharmaceutical development costs have increased dramatically, with companies seeking cost-effective solutions to maintain profitability while advancing innovation.
Time-to-Market Pressure
Competitive markets demand faster development timelines, requiring specialized expertise and streamlined processes to accelerate product launches.
Regulatory Complexity
Evolving regulatory requirements across global markets create compliance challenges that require specialized knowledge and proven experience.
Capacity Constraints
Limited in-house manufacturing capacity and specialized capabilities create bottlenecks in development and production scaling.
Risk Management
Need for risk mitigation strategies through diversified manufacturing partnerships and supply chain resilience.
Innovation Access
Accessing cutting-edge technologies and specialized expertise without significant capital investment in new facilities and equipment.
CDMO Market Growth Trends
Comprehensive CDMO Solutions
End-to-end contract development and manufacturing services designed specifically for pharmaceutical companies seeking reliable, compliant, and innovative partnerships.
Formulation Development
- Pre-formulation studies and feasibility assessments
- Formulation optimization and stability testing
- Analytical method development and validation
- Process development and scale-up optimization
State-of-the-Art Manufacturing
Our cGMP-compliant facilities feature advanced manufacturing capabilities designed to support pharmaceutical companies from clinical trials through commercial production.
- ISO Class 7 & 8 cleanroom environments
- Flexible batch sizes from clinical to commercial
- Real-time environmental monitoring
- Automated quality control systems
Pre-IND to Commercial Launch Process
Pre-IND Development
Formulation development, analytical method validation, and IND-enabling studies
Clinical Trial Support
Clinical trial material production, supply chain management, and regulatory support
Tech Transfer
Seamless technology transfer and process validation for scale-up
Registration Support
NDA/ANDA preparation, regulatory filing support, and FDA communication
Commercial Manufacturing
Full-scale commercial production with continuous quality assurance
Lifecycle Management
Post-launch support, process improvements, and supply chain optimization
API Development
Custom API synthesis, characterization, and scale-up services for pharmaceutical applications.
- • Route scouting and optimization
- • Impurity profiling and control
- • Regulatory documentation support
- • Supply chain risk management
Analytical Services
Comprehensive analytical testing and method development for pharmaceutical quality assurance.
- • Method development and validation
- • Stability testing programs
- • Impurity identification
- • Bioanalytical services
Regulatory Consulting
Expert regulatory guidance and support for global pharmaceutical submissions and compliance.
- • IND/NDA/ANDA preparation
- • FDA meeting support
- • Global regulatory strategy
- • Compliance auditing
Why Pharmaceutical Companies Choose SGP Care
Strategic advantages that make SGP Care the preferred CDMO partner for innovative pharmaceutical companies.
Cost Reduction
Average development cost savings through strategic outsourcing partnerships
Faster Timeline
Accelerated time-to-market through specialized expertise and streamlined processes
Quality Rate
Product quality and regulatory compliance success rate across all projects
Support
Continuous project support and communication throughout development lifecycle
Pharmaceutical Partnership Success Stories
Real-world examples of how SGP Care has helped pharmaceutical companies overcome challenges and achieve their development goals.
Biotech Company
Oncology Drug Development
Challenge
Mid-stage biotech company needed specialized expertise for complex oncology formulation development and lacked in-house manufacturing capacity for clinical trials.
SGP Care Solution
Provided end-to-end support from formulation optimization through Phase III clinical trial material supply, including regulatory guidance and analytical support.
Results
- 18-month reduction in development timeline
- 40% cost savings compared to alternative approaches
- Successful FDA approval and market launch
Pharma Corporation
Generic Drug Portfolio Expansion
Challenge
Large pharmaceutical company wanted to expand generic portfolio but faced capacity constraints and needed specialized analytical capabilities for complex formulations.
SGP Care Solution
Delivered comprehensive ANDA development services including bioequivalence studies, analytical method validation, and commercial manufacturing setup.
Results
- 12 ANDA approvals within 24 months
- Scalable commercial manufacturing platform
- Ongoing partnership for portfolio expansion
CDMO Partnership ROI Calculator
Estimate the potential cost savings and timeline benefits of partnering with SGP Care for your pharmaceutical development needs.
Project Parameters
Potential Benefits
Cost Savings
$6.0M
60% reduction in development costs
Time Savings
12 months
50% faster time-to-market
Risk Reduction
75%
Lower development risk through expertise
Partnership Process
Our streamlined approach to establishing successful pharmaceutical development partnerships.
Initial Consultation
Comprehensive project assessment and feasibility evaluation
Proposal Development
Detailed technical and commercial proposal with timeline and milestones
Contract & Execution
Partnership agreement finalization and project initiation
Ongoing Support
Continuous project management and communication throughout development
Partner With SGP Care
Ready to accelerate your pharmaceutical development? Let's discuss how our CDMO services can support your next project.
Get Started today
777 S. Flagler Dr.
Suite 800 - West Tower
Palm Beach, FL 33401
Why Choose SGP Care?
- End-to-end CDMO services from Pre-IND to commercial
- Proven track record with 99.5% regulatory success rate
- Cost-effective solutions with up to 60% savings
- 24/7 project support and communication