It’s our job to fulfill yours
Things we can do for you
Direct hire & contract
Place qualified Life Science professionals on a full time or contract basis.
reduce the cost-to-hire
We all have strengths, staffing is ours. Let us save you time and efficiently provide qualified resources for any phase of your project.
Life Science Market
Life Science is our only focus!
Pharmaceutical
Biotechnology
Medical Devices
MARKETPLACE
- Regulatory Submissions (ex.- Premarket Approval PMA, 510(k), CE Marking, NDA/INDs, ANDAs, etc.) and Compliance
- Post Market approvals
- Medical Device Directives (MDD)
- CMC Regulatory
- Country-Product Registrations
- Design History Files (DHF)
-
Global/International Filings.
- Management of Notified Body Audits
- Remediation of FDA 483 Observations/Warning Letter/Consent Decree
- Specification Development and Review
- Process Establishment, Implementation, and Improvement initiatives
- Mock Inspections/Site Readiness
- GxP Audits: Routine, for cause, Pre Approval Inspection
- Quality Management Plan Development and Implementation
- Document control: review, writing and template development
- Corrective and Preventative Action Plans: Development, Implementation, and Close Out
- Regulatory response preparation and review (483 Letters)
- SOP development and review
- Validation
- Master Validation Plan (MVP) Development
- Utilities and Facilities Validation
- Process Validation (IQ, OQ, PQ)
- Equipment Qualification
-
Automation/Control System Validation
- Cleaning and Sterilization Validation (ex. – SIP, Autoclave, ETO, Gamma, etc.)
- Systems and Software (i.e. – 21 CFR part 11, electronic records, etc.)
- Packaging/Storage Stability and Labeling
- Test Method and Assay Validation
-
Analytical Method Evaluation
About MAKO LIFE SCIENCES
OUR STORY
The founder of Mako Life Sciences, Tyson Franco, has spent the past 10 years in staffing. Primarily as the #1 recruiter for the discipline in a large global recruitment firm and accomplished #1 in the company twice.
YEARS OF EXPERIENCE
NUMBER OF PLACEMENTS
TYSON FRANCO
Husband, Father, and Owner
Tyson resides in Tequesta Florida with his wife and 3 children.Location
308 Tequesta Dr
Suite #26
Tequesta, FL, 33469
Phone
(561) 567-8379 ext#1001
contact@makolifesciences.com