Regulatory Services

RAY is a leading provider of regulatory services and consultation to the pharmaceutical, biological, and medical device industries.

We have a deep understanding of the regulatory landscape and can help you navigate the complex process of getting your products to market. We have experienced and highly qualified regulatory professionals with a deep understanding of regional and global regulatory landscapes.

Regulatory Expertise

Pharmaceutical Regulatory Services: Comprehensive support for all phases of pharmaceutical product development and commercialization, from pre-submission strategy and regulatory submissions to post-approval support.
Biologics Regulatory Services: Guidance for regulatory strategy development, submission preparation, and post-approval activities for biologics, including monoclonal antibodies, vaccines, and gene therapies.
Medical Devices Regulatory Services: Specialized expertise for navigating the complex regulatory landscape for medical devices, providing guidance throughout the product lifecycle from pre-market submission to post-market surveillance.

RAY provides comprehensive regulatory compliance consulting to help your products meet all applicable regulations. Our experienced team guides you through the complexities of the regulatory landscape, minimizing risks and ensuring smooth market access.

Our services include:

Regulatory Gap Analysis
Compliance Audits
SOP Development and Review
Training and Education Programs
Regulatory Due Diligence
Compliance Monitoring and Reporting

At RAY, our experienced professionals will work closely with you to develop a tailored strategy that aligns with your business objectives, maximize market access. and meets global regulatory requirements.

Our services include:

Pre-submission meetings and interactions with regulatory agencies
Risk assessments and mitigation plans
Regulatory intelligence and trend analysis

RAY’s regulatory experts assist sponsors in navigating complex submission requirements to improve success rates. Our experienced team is dedicated to offering strategic support from planning to final submission.

Our services include:

Technical File & Dossier Preparation
Regulatory agency interactions to ensure a smooth review process.

We provide ongoing regulatory support after market approval, including variations, renewals, and compliance with post-marketing commitments for both pharmaceuticals and medical devices.

We specialize in the preparation and submission of Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD), streamlining the approval process for pharmaceuticals.

We ensure that your product labeling and packaging meet all regulatory requirements, including content, design, and language specifications, for both pharmaceuticals and medical devices.

We provide regulatory review to ensure promotional materials meet regulatory requirements and are compliant with local and international guidelines.

RAY helps companies achieve and maintain GMP compliance.
Our experts guide implementation, training, and gap analysis.
Our services include facility design, equipment validation, process control, and documentation.

RAY ensures compliance and a successful inspection outcome through customized training, mock inspections, and documentation review.

RAY offers comprehensive training programs for pharmaceutical, biologics, and medical device professionals.
Our training courses cover a wide range of regulatory topics, including regulatory requirements, submission strategies, and compliance best practices.
We provide both in-person and online training options.

Regulatory Services

Regulatory Expertise

Our services include:

Our services include:

Our services include:

Head Office

RAY-PSP

UAE OFFICE

KSA OFFICE