Providing lifecycle consulting, project execution, and market entry strategies
For established healthcare manufacturers and startup enterprises
We are founded on the premise that good science, followed by good engineering and regulatory compliance, results in safe and successful products.
Clear expectations, transparent delivery, and a right-sized engagement model.
No project is too small - some projects are too big. We will inform you early in the procurement process if your needs exceed our capabilities — and then direct you to appropriate firm partners in your region to assist.
We have programs tailored from Fortune 100 conglomerates, to individual inventors, and startups to meet your program goals.Our transparent cost structure and ISO compliant supplier documentation make on-boarding easy.
MOAP differentiates by providing the correct resource by expertise, geographical market, and business need without the bloat and overhead of typical life science consulting firms.We pride ourselves on being easy to work with to meet purchasing control requirements.
Strategic Consulting
- Product Concept and Regulatory Strategy
- Investment and Timeline Development
- Outsourcing & Offshoring Assessment
- Pre-PAI Audits
- Facility Design & Risk Assessment
- Regulatory Action Response Planning
- Technology and Alternate Options
- M&A due diligence (QMS/Product/Manager)
- Risk Management
Tactical Consulting
- QMS Development & Remediation
- Design History creation/remediation
- Facility Design/Build
- Design Validation
- Process Validation (Technical Systems)
- Facility Validation
- GAMP 5 Product/Process Validation
- Auditing (Internal/External)
- Process Optimization (TMS/Technology)
- CAPA Remediation
- MDCAS Preparation
Our Team and Ethics
MOAP has over 300 collective years of expertise in the healthcare space. Our staff includes executives, scientific, and engineering professionals all with industry experience. We have helped over 30 organizations achieve their goals over 32 years of doing business. Please reach out to obtain CV's of our key staff.
On all projects - we consider ourselves to be agents of the public health. Data integrity and reliance on objective evidence are foundational. If asked to deviate from these principles, we politely exit the relationship, with full NDA compliance.