We provide services in the areas of:
· Regulated (CMC) chemistry, manufacturing and controls of bio and non bio-pharmaceuticals including scientific, regulatory and GXP aspects.
· Toxicology (developmental, regulatory, forensic, occupational, clinical and environmental aspects)
Our service and expertise cover the following areas:
· Advising with strong and proven quality assurance tools to biotech organizations on their development plan from the incubation to a clinical stage company.
· Supporting bio and cleantech projects with focused and precised CMC decisions in an environment of GXP (GMP, GLP, GCP, GDP) structure for project reliability from venture fund’s perspectives.
· Scientific evaluation vs. pharmaceutical and/or environmental international regulatory requirements.
· Validation project management.
· Strategic support and smart integration of the technology for multinational clinical trials management.
· Technology transfer.
· Training, coaching and knowledge transfer.
· Worldwide Inspection of Clinical, Non-Clinical and Doping Control Laboratories for compliance with ISO 17025 , ISO 15189 and WADA Standards.
· Advising clients on questions regarding classifications, regulatory processes and submissions to national agencies (health, production, environmental protection) of different geographical locations for pharmaceutical, food, chemical, production sites.
· Expert support on quality and scientific issues on alcohol and drug enforcement procedures. Watchdog for scientifically related indictment procedures which comply with those express in the current law or governmental statutes and codex. Expert witness experience including: alcohol/drugs and driving under the influence (DUI), blood and urine drug testing, forensic pharmacokinetics, and the toxicological effects of xenobiotic and toxic substances in the workplace and the environment.
· Scientific and quality support to attorneys at law in preparation of class actions litigation package in the US, EU, Africa and the Middle East.