Contract Research Organization (CRO)
We provide comprehensive Contract Research Organization (CRO) services to pharmaceutical, biotechnology, and academic organizations worldwide, supporting their drug development programs with precision and reliability. Our mission is to accelerate innovation while ensuring compliance with global regulatory standards and maintaining the highest levels of quality.
- Engagement Models
- Operational Excellence
- Quality & Compliance
- Strategic Partnership
Engagement Models
- Full-Time Equivalent (FTE): Dedicated scientific staff allocated exclusively to a sponsor’s projects, ensuring continuity, deep project knowledge, and long-term collaboration.
- Fee-for-Service (FFS): Flexible, task-based outsourcing that delivers cost efficiency and scalability for short-term or specialized needs.
Operational Excellence
- Defined project timelines: Milestones agreed upon upfront to guarantee predictable progress.
- Regular status updates: Transparent communication through weekly reports, dashboards, and review meetings.
- Agile project management: Rapid response to evolving requirements ensures adaptability and efficiency.
Quality & Compliance
- Certificates of Analysis: Comprehensive documentation for synthesized APIs, intermediates, and clinical trial materials, validated against international guidelines.
- Confidentiality: Strict agreements and secure data management systems safeguard sponsor intellectual property and research integrity.
Strategic Partnership
Strategic Partnership
By combining flexible engagement models (FTEs and FFS), robust drug discovery capabilities, timely execution, transparent communication, validated deliverables, and unwavering confidentiality, our CRO serves as a trusted partner in advancing pharmaceutical innovation.
Contract Manufacturing
We are recognized manufacturers of bile acid-derived Active Pharmaceutical Ingredients (APIs), specifically tailored for the treatment of cholestatic disorders. Through strategic contract manufacturing partnerships, we ensure high-quality production at certified facilities that meet global standards.
Niche Chemistry
Expertise in synthesizing complex bile acid derivatives.
Analytical Support
Comprehensive characterization and validation techniques.
Regulatory Compliance
Full adherence to IP, BP, and USP standards.
Quality Assurance
Rigorous control systems for consistency and safety.
Custom & Fine Chemical Synthesis
From small molecules to complex derivatives, we specialize in tailoring products with precision—accommodating a wide range of functional group substrate scopes.
We proudly serve a global clientele spanning pharmaceuticals, agrochemicals, biopharma, and beyond. Our specialization in fine and specialty chemical synthesis includes a proven track record in developing niche compounds and orphan drugs.
Scientific Rigor:
Our team excels in route scouting, designing robust synthetic methodologies, and delivering analytical data support that ensures quality and reproducibility.
Active Pharmaceutical Ingredients (APIs)
Route Scouting
Innovative and efficient synthetic pathways designed for scalability and sustainability.
Technology Transfer
Seamless handover from lab to plant, ensuring reproducibility and compliance.
Documentation
Detailed Process Development Reports supporting regulatory filings and internal validation.
Strategic Sourcing
Sourcing of high-quality APIs, intermediates, reagents, building blocks, fine chemicals and solvents, leveraging a robust network of trusted partners both domestically and internationally.
Quality Assurance
Every product meets stringent specifications and complies with global regulatory standards.
Timely Delivery
Streamlined logistics and proactive planning ensure consistent, on-time supply.
Regulatory Support
Full documentation and support for regulatory authorities, enabling smooth approvals.
Reliability & Peace of Mind
Whether you’re scaling up production or navigating complex regulatory landscapes, our sourcing and supply capabilities ensure reliability and transparency.
APIs
Intermediates
Solvents
Formulation Research
Standalone or fully integrated formulation solutions tailored to your product objectives.
Service Capabilities
- Pre-formulation Assessment – characterization of physicochemical traits and excipient compatibility
- Formulation Engineering & Refinement – creation of stable dosage forms tailored to product objectives
- Process Engineering & Enhancement – designing efficient, reproducible manufacturing processes
- Validation Programs – thorough process qualification to meet regulatory standards
- Analytical Method Design & Qualification – establishing dependable testing methodologies
- Scale-Up & Technology Deployment – seamless transition from laboratory scale to commercial production
Stability Evaluation
- Accelerated, Intermediate & Long-Term Stability Protocols
- Stress Testing / Forced Degradation – measuring product durability under extreme conditions
- Drug–Excipient Interaction Studies
- Light Sensitivity / Photostability Testing
Dosage Form Expertise
- Solid Orals: Tablets, Capsules, Pellets, Powders, Granules
- Liquid Preparations: Oral solutions and suspensions
- Semi-Solids & Dermatologicals: Creams, gels, ointments
- Specialized Formats: Ophthalmics, Injectables, Lyophilized products
Let's build the future of medicine together.
Partner with Athena Pharma for precision chemistry, reliable sourcing, and innovative formulation.