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
CECON provides pharmaceutical business support:
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
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
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)