Welcome to our comprehensive Regulatory Affairs service, where we assist companies in navigating the intricate landscape of regulatory compliance and product approval. Our dedicated team of regulatory experts is well-versed in global regulatory requirements, enabling us to provide strategic guidance and support throughout the regulatory process.

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Regulatory affairs services

Navigating the Complexities of Compliance and Product Approval

Our Regulatory Affairs services offer comprehensive support in navigating regulatory compliance and product approval. With expertise in global regulations, we provide strategic guidance, assistance with product registration and submission, compliance review for labelling and packaging, post-market surveillance support, regulatory intelligence, and training programs. With a deep understanding of local and global regulations, we provide exceptional regulatory affairs services to help bring your products to market quickly and compliantly.
Reach out to us now and start the journey towards success!

Our services include

● CP (EU), DCP (EU, MENA), NP (EU, MENA), Variations and Renewals
● Gap Analysis
● Full Submission and Regulatory Support
● Module 1 preparation including:
○ Cover letter
○ Application form (eAF)
○ Artwork and Braille
○ Consultation with Target Patient Groups (Readability Testing in all EU languages)
○ Environmental Risk Assessment
● Module 2 preparation:
○ 2.4 Nonclinical Overview
○ 2.5 Clinical Overview
○ 2.6 Nonclinical Summary
○ 2.7 Clinical Summary
● Module 3 preparation
○ CMC quality data and information
● Publishing
○ eCTD Publishing
○ Nees/CTD to eCTD
● Submission to Agency
● Regulatory Intelligence

Partnering with our Regulatory Affairs services ensures that you navigate the complex regulatory landscape with confidence, saving time and resources while mitigating compliance risks. We are dedicated to supporting your regulatory needs and helping you bring safe and effective products to market. Contact us today to discuss your specific regulatory challenges and let us guide you towards successful regulatory compliance and product approval.

Why us

Regulatory Expertise

Our team possesses in-depth knowledge of regulatory frameworks and requirements across various regions. We stay up to date with the latest regulations, guidelines, and industry trends, ensuring that your products meet the necessary compliance standards.

Product Registration and Submission

We offer end-to-end support for product registration and submission, guiding you through the regulatory pathways for market authorization. From compiling the necessary documentation to liaising with regulatory authorities, we streamline the submission process to accelerate approval timelines.

Compliance and Regulatory Strategy

We develop customized regulatory strategies to meet your specific business goals. Our experts assess the regulatory landscape, identify potential risks and challenges, and devise effective strategies to mitigate those risks while ensuring compliance with applicable regulations.

Labelling and Packaging Compliance

Our services encompass comprehensive review and assistance in labelling and packaging compliance. We ensure that your product labels and packaging materials comply with local and international regulatory requirements, including accurate ingredient listings, warnings, and usage instructions.

Post-Market Surveillance

We provide support for post-market surveillance activities, including adverse event reporting and product safety monitoring. Our team assists in the preparation of periodic safety update reports (PSURs) and ensures timely compliance with pharmacovigilance requirements.

Regulatory Intelligence

We closely monitor regulatory changes and updates, providing you with valuable insights and analysis. Our regulatory intelligence services help you stay informed about evolving regulations, potential impact on your products, and opportunities for regulatory optimization.

Training and Compliance Education

We offer training programs and workshops to enhance your team's understanding of regulatory requirements and best practices. Our customized training sessions cover topics such as regulatory compliance, quality management systems, and documentation practices.

Get In Touch

We value your input and always appreciate feedback. Your suggestions and comments help us improve our services, ensuring that we consistently meet your needs and exceed your expectations.

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MO - FR 9:00 am - 5:00 pm

+ 420 774 557 550


Czech Republic,
Nile House, Karolinská 654/2, Karlín, 186 00, Prague