The Science and Regulatory practice at Mandala Partners International
Mandala Partners' business is to provide strategic and tactical consulting that helps clients achieve their growth objectives in the healthcare and life sciences fields. We work collaboratively, taking pride in developing specific and practical solutions to progress the Development, Registration and Optimization of Pharmaceutical/Medical Products.
Our role is to be an advisor and colleague providing clinical and regulatory judgment, development experience and market intelligence. The success of our firm is built on our insight into the healthcare sciences, uniqueness of project needs, Regulatory agency expectations and people dynamics. The quality, integrity and expertise of our members ensure that, together with you, we develop leadership solutions which your team owns.
Our scientific and regulatory services include:
PRODUCT DEVELOPMENT AND REGISTRATION
- Clinical Strategies and plans for:
- First in man studies
- Proof of principle and product validity
- Full clinical development
- Enhancement of marketed products
- Product Safety Evaluation
- Manufacturing/Controls plans for:
- Clinical Trial supplies
- Commercial final product
- CMC sections for applications (particularly Biotechnology products)
- Regulatory strategies and tactics for:
- Liaison with regulatory agencies (to support all phases of product development and registration)
- IND/CTA/CTX filings
- Pre-IND, end of Phase II, pre-NDA meetings
- Worldwide registration filings/regulatory plans for product approval
- Resolution of Product Safety Issues
- Strategic guidance
- Presentation development
- Technical Support
- Liaison with academic thought leaders
- Product positioning, promotion and safety
- Product or business acquisition
- Strategic alliances
- Investment decisions