Pharmaceutical / Biopharmaceutical / Medical Devices / Regulatory

Drug Discovery, Preclinical Drug Development, and Clinical Development

We have over 200 pharmaceutical experts with an average of more than 25 years of experience offering comprehensive technical support in all areas of the drug development life cycle - including drug discovery, preclinical drug development, CMC, regulatory strategy and submissions, and commercialization.

Contact us to help you find the best consultant, see our pharmaceutical experts listed by a specific discipline, or perform your own key word search.

Discovery

• Medicinal Chemistry (SAR,Patent search and evaluations)
• Biology (Target identification and validation, Screening paradigms)
• Drug Metabolism and Pharmacokinetics (DMPK) (Metabolic stability, Cassette Dosing)
• CMC (chemistry, manufacturing and controls)(Preformulation)

Preclinical Development

• Toxicology (Dose Ranging, GLP studies, Safety pharmacology)
• DMPK (Metabolite identification and quantification, CYP inhibition and induction, Toxicokinetcs)
• CMC (Formulation development, Pharmaceutical Analysis, Dissolution and stability)
• Regulatory affairs (FDA interactions, IND submissions)

Clinical Development

• Phase I-IV studies (Clinical development plan, study design. study execution, studying monitoring, Clinical study reports)
• CMC optimization (Marketed dosage form, Manufacturing technology, extraction, purification, freeze drying (lyophilization), dosage forms, Packaging)
• Toxicology studies (Carcinogenecity studies)
• DMPK (Mass balance/excretion studies, Metabolite identification and quantification, Drug-drug interactions studies)
• Statistical analyses
• Regulatory affairs (FDA meetings, NDA submissions, Electronic filings)

Chemistry, Manufacturing, and Controls (CMC)

Manufacturing support for:

• Raw materials and API development
• Drug formulation
• Pharmaceutical packaging
• Process development and Validation
• Pharmaceutical quality assurance and auditing
• Supply chain
• CMC regulatory
• CMC tech transfer

Laboratory support for:

• USP methods and testing
• LIMS and laboratory automation
• Specialized techniques in analysis
• Laboratory planning and design

Regulatory Strategy and Submissions

CECON can provide on-site expert support in regulatory matters to expedite drug development.

• Validation in Manufacturing Process, Cleaning, Software
• Analytical Laboratory Certification
• cGMP, GLP and GCP Compliance
• Pre-approval Inspection Preparation
• IND/ NDA/ ANDA
• Prepare drug master files
• Qualification of Facilities and Equipment in IQ / OQ / PQ
• Establish USP Liaison and Compendial Method Development
• Pharmaceutical Regulatory and Labeling

Pharmaceutical Business Support

• Marketing research - fine chemicals, API, channels of distribution
• Licensing
• Project planning and management
• FDA liaison
• Market access
• Economics and cost studies

Medical Devices

These medical device 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; Class III PMA requirements
• Synthetic body parts (artificial limbs, orthopedic implants, artificial organs)