Innoworks Circle of Experts
Have a tough pharmaceutical problem? Contact Innoworks.
Innoworks acts as a technical expert broker by linking subject matter experts and consultants with clients requesting specific technical or business information or problem solving skills.
Since 2009, Innoworks has developed a worldwide network of consultants specializing in drug discovery, product development, clinical research, market research, pharmaceutical material science, engineering and business issues.
We provide customized search support to help you find the expert you need as consultants and legal expert witness. We are capable of quickly linking client needs with consultant expertise and availability.
We have a rich database of distinguished pharmaceutical / technical subject matter experts (SME) of over 100 experts with pharmaceutical technical experience within 45 specialty areas, from drug discovery to clinical trials, manufacturing, testing, patent and intellectual property, Quality-by-design, QA and regulatory, novel drug delivery, Audits, Product life cycle management, Business process improvement, Project management, SME for law firms etc.
SME for Drug development and Intellectual Property:
SME for Pharmaceutical business support and Project Management:
SME for Pharmaceutical Manufacturing and Laboratory Support:
Manufacturing experts can help with:
Laboratory support for:
SME for QA and Regulatory Support :
Innoworks can provide on-site expert support in regulatory matters to expedite drug development.
SME for 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.
Innoworks acts as a technical expert broker by linking subject matter experts and consultants with clients requesting specific technical or business information or problem solving skills.
Since 2009, Innoworks has developed a worldwide network of consultants specializing in drug discovery, product development, clinical research, market research, pharmaceutical material science, engineering and business issues.
We provide customized search support to help you find the expert you need as consultants and legal expert witness. We are capable of quickly linking client needs with consultant expertise and availability.
We have a rich database of distinguished pharmaceutical / technical subject matter experts (SME) of over 100 experts with pharmaceutical technical experience within 45 specialty areas, from drug discovery to clinical trials, manufacturing, testing, patent and intellectual property, Quality-by-design, QA and regulatory, novel drug delivery, Audits, Product life cycle management, Business process improvement, Project management, SME for law firms etc.
SME for Drug development and Intellectual Property:
- Drug delivery, formulation, controlled release dosage forms.
- Drug preformulation, dissolution and stability.
- Pharmaceutical Analysis.
- Drug Metabolism and pharmacokinetics.
- Safety assessment and toxicology.
- Clinical trials, protocol design and management.
- Diagnostics, radio -pharmaceuticals and oncology.
- Organic and medicinal chemistry.
- Chemistry, manufacturing and controls (CMC).
- Manufacturing technology, extraction, purification, freeze drying (lyophilization), dosage forms, packaging and inventory control.
- Patent preparation and litigation.
- Bio-pharmaceuticals.
- Prepare formulation development desgign and development strategy.
SME for Pharmaceutical business support and Project Management:
- Marketing research - fine chemicals, API, channels of distribution, and so on.
- Licensing.
- Project planning and management.
- FDA liason.
- Economics and cost studies.
- Acquisitions and joint ventures.
SME for 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.
- Trouble shooting in production.
- Off-shore 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.
SME for QA and Regulatory Support :
Innoworks can provide on-site expert support in regulatory matters to expedite drug development.
- OA/QC Systems Development and Management.
- Validation in Manufacturing, Process, Cleaning software.
- Analytical laboratory certification.
- cGMP, GLP and GCP compliance.
- Pre-approval inspection preparation.
- Business Process Improvement.
- Preparation of Drug Master files.
- Qualification of facilities and equipments - IQ/ OQ/PQ.
- Training per cGMP. Prepare and review of CMC section of IND, NDA and ANDA.
- Establish USP Liason and Compendial Method Development.
SME for 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 elastomer, bio metals and bio composite materials.
- Bio- medica; engineering and design.
- Bio-compatibility.
- Testing and validation.
- 510 K registration, FDA requirements.