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.
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