REGULATORY AFFAIRS
Regulatory Affairs is a critical function within the life sciences industry, ensuring that products—whether pharmaceuticals, biologics, or medical devices—comply with all applicable laws, regulations, and standards throughout their lifecycle. This includes development, approval, manufacturing, and post-market activities.
At JVM Global Inc., we provide expert Regulatory Affairs support to help clients navigate complex global regulatory environments with confidence and efficiency. Our team of experienced professionals ensures that your products meet regulatory requirements while minimizing time-to-market and avoiding compliance risks.
Our Regulatory Affairs services include:
- Regulatory strategy and submissions (IND, NDA, ANDA, BLA, 510(k), PMA)
- Preparation and review of regulatory documentation
- Liaison with regulatory bodies (e.g., FDA, EMA, MHRA, Health Canada)
- Support for global product registrations and market entry
- Labeling, packaging, and advertising compliance
- Lifecycle management and change control
- Regulatory intelligence and risk assessment
We serve clients in pharmaceuticals, biotechnology, and medical devices, ensuring their products align with evolving regulatory standards across the U.S., Europe, and global markets.
Our Services
COMPUTER SYSTEMS VALIDATION
Computer System Validation (CSV) is a formal, documented process mandated by regulatory authorities worldwide to ensure that…
HEALTHCARE AND PHARMACEUTICALS
The Healthcare and Pharmaceutical industries are among the most regulated and innovation-driven sectors in the global economy…
MEDICAL DEVICES
The Medical Device industry operates at the intersection of technology, innovation, and patient care. With growing regulatory scrutiny…
REGULATORY AFFAIRS
Regulatory Affairs is a critical function within the life sciences industry, ensuring that products—whether pharmaceuticals, biologics…
QUALITY ASSURANCE
Quality Assurance (QA) is a wide concept and covers all aspects that could have an impact on the quality of prescribed pharmaceutical products..
INFORMATION TECHNOLOGY
We provide services under the Information Technology for services like Java, DevOps, .net, Sales Force, SAP, Oracle, AWS..
CLEANING VALIDATION
As a pharmaceutical professional, you are faced with the ongoing challenge of ensuring the quality, safety, and efficiency..