Our Services
Pharmaceutical Regulatory Affairs
Medical Device Regulatory Affairs
Food Supplements
Herbals & Ayurvedic
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Pharmaceutical Project Management
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Medical Device Regulatory Affairs


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:

Technical Files

Design Dossiers

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)

Our Advantage
Success and Us
Everything and Anything

Spark Pharma Regulatory is managed by a industry trained regulatory professional having invaluable Pharma experience from Reputed pharmaceutical company.

We assist our clients by guiding the product development in line with the country specific requirements, data generation, document compilation for submission to various Regulatory Agencies all over the world.

The registration being the pre-requisite for export to any market, the client gets all round assistance in technical data generation and regulatory strategy to enter new markets. Thus, enhancing their market portfolio and revenues.