Pharmaceutical Teams
Summary
CECON has more than 200 experts in the area of pharmaceutical technology,
many with decades of experience. These people cover most technical pharma
subjects, including drug discovery and medicinal chemistry, API testing and
drug toxicity, dosage forms (oral, injectable, IV, controlled release),
formulation including excipients and bio-pharmaceutical drugs.
CECON provides experts for all aspects of regulatory matters and compliance (GMP, GLP, GCP), QA/QC, validation services and FDA special issues such as preparing packaging, labeling, ANDA submissions and working on FDA consent decrees.
CECON Helps You By:- Assisting in your effort to manage FDA regulation and other compliance issues.
- Providing pharmaceutical talent to small firms needing specialized help, such as API synthesis, drug metabolism and pharmacokinetics studies, drug safety and toxicity, controlled release formulations, lyophilization and dosage forms, such as parenteral products.
- Providing analytical teams to develop methods and certify analytical labs and instruments according to GMP requirements.
- Conducting due diligence, technology valuation, opportunity assessments and licensing assistance for patents and technology packages.
- FDA audit: Quickly placed team of experts in a pharmaceutical laboratory to meet FDA GMP audit.
- Drug metabolism: Pharmacokinetics expert helped small firm with Phase 1 studies, including defining lab work, data revue and IND preparation.
- ANDA filing: Team of 3 consultants helped German firm quickly file an Abbreviated New Drug Application (ANDA) with the FDA.
- Product labeling: Former FDA official helped small firm gain FDA approval for labeling medical liniment.
- Regulatory compliance: Expert repeatably traveled to Europe to support manufacturing facility for FDA submissions and compliance.
- Technology review: Review formulation details of parenteral product.