What We Offer
Comprehensive regulatory affairs services designed to move your products from concept to market — efficiently, compliantly, and with confidence.
We provide expert guidance on regulatory requirements, ensuring seamless interaction with regulatory authorities and compliance with applicable standards. Our team works hand-in-hand with the Pharmacy and Poisons Board (PPB) and other relevant bodies to ensure your products meet all local requirements while aligning with international standards.
We work closely with clients to design effective market access and regulatory strategies that support business growth and product lifecycle management. We streamline approvals and certifications, ensuring your products reach healthcare providers and end consumers without unnecessary delays — your gateway to market success.
Our team ensures accurate, complete, and timely preparation of regulatory submissions to minimize delays and facilitate approvals. We compile, review, and format complete technical dossiers to required standards — CTD format, ACTD, or authority-specific formats — ensuring every document meets scientific and administrative requirements before submission.
We offer ongoing support including compliance monitoring, variations, renewals, and pharmacovigilance/technovigilance activities. Regulatory obligations don't end at approval — we ensure your products remain compliant through their full lifecycle, with proactive management of all post-market requirements.
We review product labels and packaging artwork against applicable regulations — checking claims, mandatory information, language requirements, and format compliance — for medical devices, food supplements, cosmetics, and pharmaceuticals across all target markets.
We offer customized training programs for in-house regulatory, quality, and marketing teams — covering regulatory frameworks, GMP principles, documentation best practices, and EAC standards to build lasting internal capabilities.
We manage the regulatory side of cross-border trade — securing import permits, certificates of free sale, GMP certificates, and coordinating with customs authorities for regulated products entering or leaving East African markets.
We support companies in implementing and maintaining quality systems compliant with ISO 13485 (medical devices), ISO 22000 (food safety), and GMP standards required by regulatory authorities — from initial gap analysis to audit readiness.
We don't just navigate regulations — we master them. Here is what sets Marsland apart as East Africa's trusted regulatory consulting company.
We streamline approvals and certifications, ensuring your products reach healthcare providers and patients without unnecessary delays.
Our team works hand-in-hand with the Pharmacy and Poisons Board (PPB), Kenya's national regulatory authority, ensuring your products meet all local requirements while aligning with international standards.
We collaborate with manufacturers, distributors, and healthcare providers to deliver compliant solutions that improve lives across East Africa.
From product classification and technical documentation to approvals and post-market surveillance, we guide you through every step of the regulatory journey.
We understand Kenya's regulatory landscape inside out, while aligning with international frameworks such as ISO 13485, WHO guidelines, and ICH standards.
Customized services designed to meet the unique needs of startups, SMEs, and established organizations — with flexible models that reduce overhead and provide predictable costs.