Pharmaceutical / Medical Devices / Regulatory
CECON Offers a Broad Range of Pharmaceutical Technical Consultants
We have over 180 experts with pharmaceutical technical experience within 20 specialty areas, from drug discovery to clinical trials, manufacturing, and delivery.
- Drug preformulation, dissolution and stability
- Drug Delivery: Dosage forms, formulation, controlled release
- Pharmaceutical Analysis
- Drug metabolism and pharmacokinetics
- Safety assessment and toxicology
- Clinical trials, protocol design and management
- Diagnostics
- Organic and medicinal chemistry
- Chemistry, manufacturing, and controls (CMC)
- Manufacturing technology, extraction, purification, freeze drying (lyophilization), dosage forms, packaging and inventory control.
- Patent preparation and litigation
- Bio pharmaceuticals
CECON can also provide pharmaceutical business support:
- Marketing research - fine chemicals, API, channels of distribution, and so on
- Licensing
- Project planning and management
- FDA liaison
- Economics and cost studies
- Acquisitions, joint ventures
Pharmaceutical Manufacturing and Laboratory Support
Manufacturing experts can help with:
- Pilot plant design and engineering
- Process scale-up and unit operations
- Quality assurance/quality control
- Documentation system development
- Troubleshooting in production
- Offshore manufacturing
Laboratory support for:
- USP methods and testing
- Methods development and validation
- LIMS and laboratory automation
- Specialized techniques in analysis
- Laboratory planning and design
- Contract laboratories
Regulatory Support
CECON can provide on-site expert support in regulatory matters to expedite drug development.
- OA/QC Systems Development and Management
- Validation in Manufacturing Process, Cleaning, Software
- Analytical Laboratory Certification
- cGMP, GLP and GCP Compliance
- Pre-approval Inspection Preparation
- Prepare master drug files
- Qualification of Facilities and Equipment in IQ / OQ / PQ
- Training per cGMP Ball Prepare and Review of CMC Section of IND, NDA and ANDA
- Establish USP Liaison and Compendial Method Development
Medical Devices
These experts understand bio materials, system design and regulatory requirements necessary to develop, manufacture and integrate such devices into to living systems.
- Bio-materials development and fabrication
- Bio polymers, bio elastomers, bio metals and bio composite materials
- Bio-medical engineering and design
- Bio-compatibility
- Testing and validation
- 510K registration; FDA requirements
- Synthetic body parts (artificial limbs, orthopedic implants, artificial organs)