Services

Business: we can help formulate business plans, raise capital, interface with bankers/investors, refine development strategies, help define priorities

Product development, technical management: we can help formulate /prioritize requirements, assist development, analyze faults, resolve problems, interface with vendors

Testing, V & V: we can help plan and conduct system and subsystem testing (preliminary through preclinical qualification), drafting protocols and reports structured to facilitate regulatory review

Design controls, risk mgt., manufacturing transfer: we can help establish a design control system, draft specifications and mfg procedures, participate in design reviews, guide risk management activities

Quality Assurance: we can help set up a Quality System, conduct gap analyses and internal audits, review documents, guide CAPA activities, prepare for audits

Clinical trials: we can help develop a test plan, draft the study protocol and CRFs, interface with biostatisticians and CROs

Regulatory affairs: we can help develop regulatory strategy, assist in communications with regulators, draft or review submissions, respond to agency questions