Regulatory & Technical Services
Our team of highly-qualified industry experts ensure compliance across all the relevant regulatory, medical information and drug safety fields for us and for our partners.
Seamless solutions
Whether you have inhouse resources or are seeking extra support, our compliance experts successfully navigate the regulatory landscape so you can focus on what you do best. A culture of compliance runs through the business, ensuring that all standards are met across the full product lifecycle.
Regulatory
Our Regulatory and Compliance team stays abreast of the evolving regulatory landscape in all core markets and ensures that our recommended product lifecycle management and processes consistently meet with all local requirements and standards.
We are subsequently able to identify and execute regulatory pathways, offer regulatory guidance and landscaping, and establish and deliver effective recommendations for you in areas including the registration processes in the target market.
Drug Safety
Based on the core principles of detecting, assessing, understanding, and preventing side effects, our pharmacovigilance team collaborates closely with your drug safety team to develop and implement a fully customised solution aligned with your internal processes and procedures.
Medical Information
We manage the dialogue concerning the clinical aspects of rare disease medicines with doctors, nurses, pharmacists, and other relevant healthcare professionals. Our medical information solutions are designed to provide accurate and current knowledge to healthcare professionals.
Quality
Our systems are designed to ensure that all solutions adhere to the highest global quality standards. We employ a rigorous quality assurance process that includes comprehensive QMS management and audit programs, guaranteeing the integrity and reliability of our services throughout the product lifecycle.
Technical Compliance
Supported by our Regulatory and Compliance Office, our cross-functional project-teams work collaboratively in the creation and execution of fully compliant solutions, ensuring that all systems and products meet with regulatory requirements and achieve the highest quality standards.
“Our diligent teams always meet the correct standards, giving you peace of mind to focus on your specialist areas.”
Ready to take the next step?
Let us share how we could successfully support your product commercialisation.
