We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.
Our services include the following:
Preparation and submission of Regulatory documentation including:
Regulatory and Technical review and consulting.
Preparation and submission of registration for product applications.
Clinical Trial Applications.
Medical device vigilance and reporting systems.
Regulatory and manufacturing compliance.
Strategic and regulatory planning.
Auditing of Quality & Regulatory system to ensure compliance with required quality systems & regulations
Regulatory/Quality GAP Analysis.
Interpretation of guidance documents and legislation.
Assistance with device labeling requirements.
Liaison with Regulatory Authorities.
Provide medical device classification.
Risk Management (ISO 14971)