Biotechnology Drugs

The biotechnology companies in Israel that produce marketed drugs are less than a dozen. However, with the growing interest in immunotherapy and peptide or protein drugs, Gsap plays an important role in accelerating these companies.

Gsap built several regulatory strategic plans suitable for each biotechnology company. Our regulatory experience in the biotechnology industry includes 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.

Gsap staff has a wealth of experience in establishment, improvement and maintenance of a quality system suitable for the biotechnology industry. The quality system addresses both the most updated regulatory requirements for the specific clinical phase and the complexity of the manufacturing process, including upstream cell based and downstream purification processes.

Our multi-disciplinary team leads internal as well as external audits in the biotechnology industry. These audits are a necessary quality tool for meeting GMP requirements and authorizing suppliers. In the framework of these audits, we prepare companies for audits by the regulatory authorities.

Specific cleaning validation processes based on risk assessment tools were built to suit the complexity of the biotechnology industry. In addition, we have implemented the new quality by design approach in the biotechnology industry. This approach involves a systematic evaluation, understanding and refining of the formulation and manufacturing process, including identifying, prior material attributes and critical process parameters that can have an effect on product critical quality attributes. Enhanced product and process understanding, in combination with quality risk management, are used to establish an appropriate control strategy.Among our clients in the biotechnology industry are CureTech, SciVac, Phibro Abic, VBL, Biological Industries, Kamada, Omrix, Mediwound and Efranat.