| |
Our company offers nonclinical safety
consultancy to the pharmaceutical and industrial chemical Industry.
With 30 years experience in the development of RESPIRATORY
products, our Principal, Dr David Alexander, offers considerable expertise
in the field of respiratory drug development, inhalation toxicology and
regulatory submissions for registration of inhaled products
- Nonclinical development planning/advice, due diligence
- Preclinical strategy recommendations
- Pipeline candidate selection recommendations
- Pipeline candidate in-vitro/in-vivo screening advice
- Due diligence for in-licensing
- Nonclinical project management
- Project team member or leader if required
- Management of single study to whole programme
- Programme planning
- Study design
- Programme reviews and management summaries
- Data evaluation
- Issue resolution
- Decision analysis
- Regulatory issues
- Formulation/excipient/synthetic route change implications
- Route change implications
- Knowledge of Good Laboratory Practice (GLP)
- Knowledge of International Conference on Harmonisation (ICH) requirements
- Contract Research Organisation Liaison
- CRO recommendation
- Contract management
- Protocol preparation, development and review
- Bidding and quotation management
- Pre-study review
- Study monitoring
- Report review
- Progress report
- Peer reviewsIssue resolution
- 10-day rule awareness
- Report preparation
- Nonclinical study reports
- Regulatory submissions
- Scientific reviews
- Peer reviews
- Document preparations
- CIB
- IND
- NDA
- CTX
- MAA
- Expert reports
- Scientific papers
- Technical reviews
- In-licensing documentation
- Out-licensing documentation
- Product Information Leaflets
- Inhalation toxicology
- Study design
- Facility design
- Aerosol generation
- Aerosol sampling
- Particle size distribution
- Analytical issues
- Chamber selection and design
- Chamber monitoring
- Subject selection and recommendations
- Safety issues
- Knowledge of regulatory requirements for inhalation toxicology,
e.g. OECD.
- Leachables and Extractables
- Guidance on regulatory requirements
- Recommendations on testing strategies
- Start up Company support
- Assist in decision making processes
- Evaluate early research data
- Advise on preclinical regulations covering development candidate
- Recommend on potential pre-clinical evaluation
- Review and help identify any preclinical issues/regulatory hurdles
- Prepare preclinical presentations to VC backers/management.
- Biotechnology Product Support
- Knowledge of Preclinical regulatory guidelines
- Experience of delivery of biotech products to the respiratory
tract
- Monitoring of safety and efficacy
- Regulatory Authority Interface
- Preparation of meeting request documentation
- Preparation of meeting documentation/presentations
- Briefing of attendees
- Running practice sessions
- Attendance with client at regulatory meeting
- Presentation with the client at regulatory meetings
- Issue resolution
- Staff Recruitment
- Preparation of Job descriptions
- Resourcing Candidates
- Interviewing
- Selection recommendation
- Interim Management
- With experience of staff management and professional management
qualifications we can offer interim management of non-clinical safety
departments/staff for clients.
- Other contacts
- Our extensive network of contacts means we can supply contacts
into areas of pharmaceutical development outside our area of expertise
Please contact us
for more details.
|
|
