We are a premier regulatory consultancy firm committed to guiding pharmaceutical companies through the intricacies of local and global regulatory frameworks. With a seasoned team of regulatory experts, we specialize in providing strategic insights and comprehensive compliance solutions. Whether the client is a start-up or an established pharmaceutical company, our consultancy services are tailored to address our client's unique challenges and propel their products toward regulatory approval and commercial success. Our services include; 

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Regulatory Compliance: We Conduct regulatory compliance assessments to ensure our client's adherence to local and international regulations. 

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Regulatory Submissions: We Prepare and submit regulatory documents to health authorities for product approvals, including New Drug Applications (NDA), and Marketing Authorization Applications (MAA). We also manage interactions with regulatory agencies during the submission review process on behalf of our clients and we provide guidance on maintaining compliance throughout the product lifecycle. 

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Quality Assurance and Good Manufacturing Practice (GMP) Compliance: We Assist our clients in the development and implementation of quality systems to comply with GMP requirements, conduct GMP audits and provide recommendations for improvement. 

Clinical Trial Regulatory Support: We assist our clients with the preparation of regulatory documents for clinical trial applications, provide guidance on regulatory requirements for the design and conduct of clinical trials. 

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Regulatory Training and Education: We provide training programs on regulatory compliance, changes in regulations and keep our clients informed about the latest regulatory developments and best practices. 

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