Regulatory Affairs
Navigating the complexities of the pharmaceutical industry requires a trusted partner. We provide biopharmaceutical companies with expert regulatory guidance, ensuring compliance and accelerating market access. Our in-depth knowledge of global and local regulations enables us to deliver tailored solutions that minimize risk and maximize your return on investment.
Our Services Include:
Regulatory Strategy & Development
We specialize in creating the strategic roadmap for biopharma companies. Our experts guide you through all phases of drug development and the regulatory process to help you achieve timely approval.
Dossier Writing & Due Diligence
Our specialized teams expertly prepare all the required regulatory documents to support your product's applications, from initial development to post-market. We also conduct in-depth reviews of your existing dossiers to find and fix any gaps, ensuring they are complete and ready for submission.
Regulatory Applications & Submissions
We handle the expert preparation and submission of all regulatory documents, including dossiers and due diligence. Our team ensures your applications are meticulously prepared and submitted accurately.
Local Regulatory & Technical Representation
Expanding into new markets can be challenging. Our expertise in local regulations and compliance allows you to expand with confidence. We provide the in-country support and technical representation you need to ensure seamless and compliant operations. We act as your on-the-ground technical point of contact, ensuring all technical and regulatory matters are handled efficiently and in full compliance with local standards.
Regulatory Compliance
We help you navigate the complex world of local and international regulations. Our comprehensive assessments identify gaps in your current processes and provide clear, actionable steps to ensure you remain compliant and risk-free.
Local Regulatory Affairs
Health Authority contact
We serve as your direct point of contact with local and international health authorities.
Local Regulatory Intelligence
We provide up-to-date local regulatory intelligence to keep you informed of new laws and guidelines that may affect your business.
Artwork review and management
We ensure all product artwork and labelling are compliant with local regulatory requirements.
Promotional Materials review and approval
We review and secure approval for promotional and marketing materials to ensure they comply with regulatory standards.
Professional advice and regulatory consulting
We provide expert regulatory guidance and strategic consulting to help you make informed decisions throughout the product lifecycle.