INTELLIGENT STRATEGIES TO ENSURE SUCCESS…..
At Optimus, we combine strategic, technical, and operational capabilities to provide high-impact, expert consulting services to medical device, biologic, and combination product industries.
Our experts have particular strengths in strategic planning, regulatory strategy development & implementation, preclinical and clinical studies, product management, quality systems, auditing, validation, and regulatory compliance in India and the unique experience of designing the development program to help product approvals in the United States and Europe. An overview of our service offerings in this category include :
|PRE-CLINICAL CONSULTING||CLINICAL SERVICES||REGULATORY SERVICES||POST APPROVAL SERVICES|
|Biocompatibility||Development Plan||Strategy Development||Post marketing surveillance|
|Preclinical Studies||Clinical trial design & Implementation||Development Plan||Active surveillance|
|Development Plans||protocol Development||Approvals for pre- clinical, clinical testing||Passive surveillance|
|GLP Audits||Clinical Data Management||Post Study Approval||Case Management|
|Vendor selection & Management||Clinical Report||Marketing authorization||Quarterly & Annual Reports|
Our service offerings include consulting for regulatory affairs, preclinical, clinical trial design and management, quality systems compliance, clinical data management, biostatistics and venture capital due diligence.
We provide “intelligent strategies“ instead of simplified, often cost-intensive routine development programs to ensure highest possible regulatory acceptance of your product. We thereby ensure effective compliance and thus help you, our customers navigate the complex, medical devices regulatory landscape and make right decisions. We consider customer relationships and discretion our number one priority.
Emerging and established medical device firms trust Optimus as their partner to deliver customized strategic guidance and creative “hands-on” solutions to assess and overcome their unique regulatory, preclinical, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
Since regulation of any medical device is an integral part of R & D, we suggest a regulatory survey report to be your first step on your path to the market. Developing a wise and early regulatory strategy will prove, in the final analysis, to have been one of the wisest decisions you have taken to get your product market authorised.
The survey will include details of the classification of your product, in India, and optionally in Europe and in the USA, the route for the required approval in India, Europe and the US, the requirements for medical research (clinical trials), as and if applicable, specific Guidance (if exists), relevant for your specific product, the requirements of quality control under ISO, Software Validation Standards, and all other requirements applicable to the specific device, and a comprehensive regulatory strategy.
The team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services, from complete turn key projects which includes strategy and implementation, to ad-hoc limited projects, or just consulting hours as required to meet your specific program needs.
- Define appropriate pre-clinical and bench studies
- Develop a clinical trial design, prepare study protocols and study documents
- Identify study sites
- Obtain Regulatory / IRB / Ethics Committee Approvals
- Collect, manage, and monitor clinical trial data
- Perform statistical analysis
- Prepare clinical study report
- Obtain marketing authorisations
- Projects tracked in real time, delivered on schedule within service levels agreed upon – reducing development costs;
- Providing, localized strategic and process expertise to attain business competitiveness – delivering faster, quicker, approvable projects;
- Faster design, planning and implementation processes – leading to increased ROI;
- Improved regulatory compliance;
- Improved device / product development productivity, risk mitigation, increased revenue.