Services

Implementing Full Life Cycle Validation to Equipment, Facilities and or Process.

Guidance on compliance with FDA, EMA, and other regulatory bodies, including submissions and approvals.

Ensuring that computer system comply with regulatory requirements and including software validation and documentation.

Implementing and auditing of quality management systems, including Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

Assessment and mitigation of risks associated with product development and commercialization.

Workshops and training programs on compliance, quality management, and industry best practices.