End-to-end Regulatory Affairs Services

At RABT Global, we offer comprehensive and proficient end-to-end regulatory affairs services for the pharmaceutical and medical device industries. Our team of seasoned regulatory experts is dedicated to ensuring compliance with all relevant regulatory requirements, allowing our clients to navigate the complex landscape of approvals and certifications seamlessly. From initial product development to post-marketing compliance, we provide tailored solutions to meet your specific needs.

Our Regulatory Affairs Services:

Product Registration and Submissions:

We handle the preparation and regulatory submission of dossiers to obtain marketing authorizations and approvals for pharmaceuticals and medical devices.

Our experts are well-versed in various regulatory submission types, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Premarket Approval (PMA) applications, and 510(k) submissions, among others.

Clinical Trial Support:

Our team assists in designing and implementing effective clinical trial strategies to meet regulatory requirements and demonstrate product safety and efficacy.

We guide you through the ethical and regulatory review process to obtain necessary approvals for your clinical investigations.

Quality Management Systems:

We help establish and maintain robust quality management systems that comply with Good Manufacturing Practices (GMP) and other relevant regulations.

Our experts conduct audits and assessments to identify and address potential compliance gaps.

Labeling and Packaging Compliance:

We ensure your product labels and packaging meet all regulatory guidelines, including proper usage instructions, warning labels, and appropriate language translations.

Post-Marketing Surveillance:

Our services extend beyond product approval, assisting you with post-marketing surveillance, adverse event reporting, and product variations, as required by regulatory authorities.

Regulatory Intelligence:

Stay informed and ahead of changing regulatory landscapes with our comprehensive regulatory intelligence services.

We monitor updates, guidelines, and changes in regulations, enabling you to adapt and comply proactively.

End -to -end Regulatory Affairs Services Expertise:

At RABT Global, our team boasts extensive experience in regulatory affairs services  for pharmaceuticals and medical devices. With a deep understanding of global regulations, including FDA, EMA, CFDA, and others, we provide a well-rounded approach to regulatory compliance.