Pharmaceutical / Medical Devices / Regulatory
CECON Offers A Broad Range of Pharmaceutical Technical Consultants
A selection of technical expertise in drug discovery, clinical trials, delivery manufacture and use.
- 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
- Chemical engineering and manufacturing
- Manufacturing technology, including pharma QC, extraction, purification, freeze drying (lyophilization), dosage forms, packaging and inventory control.
- Patent preparation and litigation
- Bio pharmaceuticals
- Outsourcing, particularly with our strategic partner in India
- 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
- USP methods and testing
- Methods development and validation
- LIMS and laboratory automation
- Specialized techniques in analysis
- Laboratory planning and design
- Contract laboratories
Pharmaceutical / Medical Devices / Regulatory
CECON can provide on-site expert support in regulatory matters that can slow down the drug development program.
- 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 derived from bio-materials 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)