Pharma & biotech – regulation & registration2020-08-12T09:57:16+00:00

Regulation & registration in the pharma & biotech field

Pharmaceutical products, whether they are pharmaceutical raw materials (APIs) or a final pharmaceutical product, which are in preparation for the final stages of development and clinics, will require preparation, proper documentation and preparation of applications for registration with the health authorities such as the FDA, the European Health Authorities and of course the Ministry of Health.
Compliance with regulatory guidelines and requirements, including the submission of relevant documents, is a prerequisite for approval of product registration in the target markets to obtain a marketing authorization. Pharmaceutical product registration process in the various health authorities in the world may require professional meetings with the various regulatory bodies to help people better understand the product, its purpose and the risks involved, and make the right decisions.

The product registration process takes time, and therefore awareness of regulatory requirements and their timely action, while preparing relevant documents, can save the company valuable time and of course resources. Besides, the proper and efficient regulatory and registration process will aim as much as possible for the “low classification” of the drug, resulting in less stringent and consequently more stringent regulatory requirements, for a faster and less expensive registration process, based on the level of risk it represents.

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Regulation & registration consulting services in the pharma & biotech field

  • New pharmaceutical DS/DP global regulatory strategy

  • Biological and pharmaceutical products registration in Israel, Europe and the US

  • Veterinary products registration in Israel, Europe and the US

  • CMC writing as part of NDA file

  • Process specifications and product release specifications

  • Clinical trial plan and protocols

  • Quality management systems and GMP

  • Master documents, policies and procedures writing

  • Quality, GMP and regulatory gap analysis and mitigations

  • Subcontractors and suppliers inspection and qualification

  • Laboratory  GLP and ISO 17025 certification

  • Writing MSDS for new DS and DP

  • Qualified Person (QP) services

  • Periodical quality audits and gap analysis

  • QA & RA services

  • Risk Analysis and risk assessment

  • Preparation towards GMP audits

Other pharma & biotech services

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