Chemical Drugs

Gsap plays a pivotal role in assisting Israeli pharmaceutical and biotechnology companies in maintaining this momentum by providing a breadth of supporting services through the company's life cycle.

In the last decade the global pharmaceutical industry - including the Israeli one – prospers. This spans from start-ups spin off from academic institutions and hospitals, to innovative small/midsize companies and up to the generic large pharmaceutical companies including big pharma. Fueled by hundreds of innovative newly developed or improved drugs and biopharmaceuticals, Israel has become a global powerhouse for the industry. Gsap plays a pivotal role in assisting Israeli pharmaceutical and biotechnology companies in maintaining this momentum by providing a breadth of supporting services through the company's life cycle including:

Developing regulatory strategy for the development for the entire clinical development path i.e. R&D, proof of concept, preclinical studies and clinical trials.

Submission to the regulatory authorities (e.g. Israel MOH, FDA) including writing, review and submissions of preIND packages, IND, CMC, IMPD, clinical documents, pre-clinical protocols as well as investigator brochures, in addition to consultation with regulatory authorities.

Establishment or upgrading of Quality Management systems (e.g. GMP, GLP, ISO). Design review and validation of newly built or upgraded manufacturing facilities and laboratories often followed by preparation for the regulatory authorities' audits.

Clinical trial services (i.e. set-up, management, monitoring, documents review, auditing).

Among our pharma industry clients are: Taro, Rafa, Unipharm, Perigo, Dead Sea Works, Periclase, Intech Pharma, Solubest, Vidac, Orasis, Omnix, TPcera, N2B, Amorphical Ophtimed and Eloxx.