We provide R&D professionals who support drug and device development from pre-formulation to commercialization. Roles include Formulation Scientists, Analytical Chemists, Process Development Scientists, and Product Development Managers. Our resources bring hands-on experience in bioavailability studies, stability testing, method development, and tech transfer, supporting both small molecule and biologics pipelines. Clients benefit from deep domain expertise that accelerates innovation while meeting global development milestones.
Our validation experts ensure that facilities, equipment, and processes meet GMP and regulatory expectations. We staff Validation Engineers, CSV Specialists, Process Validation Scientists, and Cleaning Validation Experts. These professionals develop and execute IQ/OQ/PQ protocols, maintain traceability matrices, and document deviations in compliance with FDA, EMA, and WHO guidelines. Whether it’s for new facility setup or ongoing operations, our team supports compliant and audit-ready systems.
We offer regulatory professionals who guide clients through global submission and compliance strategies. Roles include Regulatory Affairs Associates, Labeling Specialists, CMC Writers, and Regulatory Submission Managers. Our consultants handle IND, NDA, ANDA, 510(k), PMA, CE Mark, and MDR filings with expertise in both pharma and device regulations. They ensure alignment with FDA, EMA, CDSCO, and TGA expectations—enabling smooth approvals and successful product launches across regions.
Our clinical staffing includes Clinical Research Associates (CRA), Clinical Trial Managers, Data Managers, and Medical Writers. These professionals support Phase I–IV trials with expertise in ICH-GCP, site management, trial documentation, and regulatory submissions. We help pharma sponsors and CROs accelerate timelines through efficient monitoring, protocol adherence, and timely reporting. Whether for biotech trials, generic studies, or device validations, our talent delivers excellence in clinical operations.
We provide QA/QC professionals who ensure products meet safety and compliance standards throughout the development and manufacturing process. Roles include QA Associates, QC Chemists, GMP Auditors, and QMS Specialists. Our staff are experienced with ISO 13485, 21 CFR Part 11, FDA QSR, and GxP systems. They support document control, batch release, deviation investigations, CAPAs, and audit readiness for both drug and device manufacturing operations.
We supply experienced professionals for pharma and device production environments. Positions include Production Chemists, Manufacturing Engineers, Equipment Operators, and Packaging Technicians. These specialists are trained in cGMP protocols, cleanroom operations, batch record review, and line clearance procedures. We support upstream/downstream processes, sterile manufacturing, and continuous improvement projects—ensuring safe, compliant, and efficient manufacturing operations.
We provide device design and compliance experts who work across the product lifecycle, from concept to post-market surveillance. Key roles include Design Engineers, Risk Management Specialists, Design Controls Experts, and Technical File Writers. Our team supports device classification, V&V protocols, ISO 14971 implementation, and EU MDR/IVDR submissions. Whether supporting 510(k) submissions or Class III implantables, our professionals ensure full compliance and engineering rigor.
+1 (732)760-5152
hr@starkpharma.com
