MJK Life Science Solutions is deeply rooted in some of the most cutting-edge and highly technical science. From biochemistry, physiology, immunology and neuroscience, to engineering, statistical analysis and IT programming–MJK will provide the technical research, writing, and advising your company needs to stay up-to-date, earn visibility, and ultimately thrive. You are not just business–you live where business and science collide.
If there’s one characteristic feature that distinguishes and unites all technology-based industries revolving around healthcare and medicine, it’s the involvement of and regulation by federal agencies such as FDA and the associated requirements for stringent regulatory and quality compliance imposed on businesses. Whether your company is developing a drug or devices, therapeutics or diagnostics, or the infrastructure and systems that support those activities, it will invariably require FDA approval, HIPAA compliance, and so forth.
MJK Life Science Solutions provides regulatory, quality, and compliance consulting and project management for life sciences and healthcare-based product development and clinical research:
- Medical writing
- Regulatory strategy
- Process optimization
- Product development
- Commercialization strategy
- Site selection and monitoring
- cGMP/GLP/GCP quality systems
- Training, auditing, and remediation
- FDA submissions and global filings
- Clinical research planning/support
For more information or to set up an appointment, contact Marc J. Kleinman: mjk@MJKlifescience.com