Regulatory Affairs & Complince

Regulatory filings of Generics ANDA/ANDS etc. to US, Europe, Canada, Japan, ASEAN Countries and Row market

Training Programme

To ensure that all employees receive adequate training in their areas of work and that the training is documented. It provides a procedure to identify, plan, execute and document training for personnel engaged in pharmaceutical manufacturing and its support activities

Articles

Articles A step by step guide for achieving compliance Drug Manufacturing and Marketing Approval Requirements in Japan Documentation – A Reliable evidence for GMP Compliance Indian Pharma Industry – Ahead in adopting in technological advancements

Training

To ensure that all employees receive adequate training in their areas of work and that the training is documented. It provides a procedure to identify, plan, execute and document training for personnel engaged in pharmaceutical manufacturing and its support activities

Regulatory Affairs and Compliance

Sai Pharma Solutions Inc. has a strong Regulatory group. Advisors from Japan, Canada, Europe, ASEAN Countries and US to have specific advice. The group has a good client list and has many US, PMDA, Japan and European approvals to their credit.

Validations

Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. Although it is mandatory from the government and regulatory bodies but it is also a fact that quality of a pharmaceutical product cannot be adequately controlled solely by

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