Stratigic Business Development Consultancy
Our team has experience in clinical practice, regulatory strategy, compliance, professional education, pharmaceutical sales and marketing, thought leader development, health outcomes localy and consulting.
We can help with strategic thinking to transform products into opportunities in pharmaceuticals, devices and combinations, in the local IL market and other regions.
Proven experience in medicine, clinical research, regulatory compliance, advocacy, guidance and support, intellectual property protection, publications, clinical collateral material development, thought leader development, professional education, pharmaceutical sales, marketing, licensing, acquisitions, and consulting.
Portfolio, Regulatory Support
- Access to professional Network in multidisciplinary fields
- Decision upon Market access, mainly in the EU/US market’s (Japan special discussion).
- Building the right portfolio and scouting for partners in Europe
- Regulatory and patent aspects (IP landscape) in the EU and regulatory gap analysis and remediation plans.
- Regulatory support in CTD submission.
- Support in regulatory facility requirements (critical systems, e.g. Water, HVAC, Nitrogen etc.)
- GMP and PAI audits.
Pre-clinical Development of innovative drugs, Re-positioning (new therapeutic entities) drugs and generics.
- Establishing NCS package of small and biological in relation to the drug mode of action, clinical stages and regulatory requirements.
- CRO selection
- Contracting, supervising and monitoring preclinical studies at the CROs.
- Writing the NCS protocols and reports according to non-GLP or GLP requirements (IB, IND, SA).
Intelectual Propety (IP) and patent related aspects
- Invalidity & Non-infringement analysis, Prior-Art searches, in-depth evaluation of patent prosecution files
- Global patent landscape reports and earliest dates for market entry determination
- Patent drafting, patent prosecution, writing non-infringement and freedom to operate (FTO) opinions
Drug Substance, Drug Product development, Troubleshooting and QbD Services
- API development and support
- Development of Drug Products Formulations
- Optimization of legacy finished dosage forms
- Turn-key Development projects – Variable costs
- Efficiency and cost saving
- Formulation Know-How (OSD, liquid, semi-liquid etc.)
- Process development (characterization, optimization, validation)
- QbD support including DoE
- Formulation and Technological Troubleshooting
- Supporting documentation (development report, BMR’s, relevant SOP‘s, Analytical methodology and validation, Development reports, CTD etc.)
- Elemental Impurities Reports according to ICH guideline Q3D
- Nitrosamine Risk Assessments report (EMA guideline)
- Data Integrity and laboratory performance.
Formulation Development
- Choosing the quantitative formula and its process of production
- Biostudy, In-vitro/in-vitro correlation
- Increase efficiency of manufacturing process
- Scale-up and process validation
- Process technological transfer from pilot to industrial scale
- Protocols, Execution and report, analytical support
- Quality by Design
- Regulatory oversight (FMEA, CQA, CMA, CPP’s, Risk Analysis etc.)
Special Services
- Data integrity
- Laboratory performance.
- Support in facility regulatory requirements
- (Critical systems, e.g. Water, HVAC, Nirtogen etc.)
- Regulatory audits etc.
- QbD: FMEA, CQA, CMA, Risk Analysis etc.