We specialize in navigating complex regulatory landscapes, ensuring compliance with industry standards and governmental requirements. Our expertise helps clients in the healthcare and wellness sectors achieve approvals, maintain certifications, and streamline processes for regulatory success.
1. Medicine:
- Dossier Review and registration: Assess completeness of drug dossiers and readiness for registration. Prepare eCTD registration files for submission to targeted regulatory authorities.
- Content Development: Address deficiencies in dossiers, including leaflet, label, and SPC development.
- Regulatory Support: Coordinating with regulatory authorities for product registration. Managing responses to regulatory inquiries until product approval.
- Product Development: Development of pharmaceutical dosage forms per FDA/EU/GCC standards
- Raw Material and Supplier Management: Sourcing approved suppliers for active and inactive raw materials. Evaluating supplier documentation (DMF) for compliance with quality standards.
- Product Development Activities: Pre-formulation and formulation studies. Development and validation of analytical methods. Stability testing and documentation.
- Bio-equivalence Studies: Selecting and contracting bio-centers for bio- equivalence protocols and studies.
2. Medical Devices:
- Technical Review: We review technical documentation to facilitate the listing of medical devices in the SFDA system.
- Label Preparation: We prepare and translate required label information to meet SFDA requirements.
3. Feed Products:
- Registration: We handle the registration of feed products and monitor their status in the SFDA system.
- Label Services: We offer label creation and modifications to ensure compliance with SFDA standards.
4. Food and food supplements:
- Food supplements are products designed to enhance one or more specific nutritional elements in the diet, containing other substances with a nutritional or physiological effect, which include, but are not limited to, vitamins, minerals, fatty acids, amino acids, enzymes, Prebiotics and probiotics, collagen, dietary fibers, melatonin, propolis, pollen, herbs or dietary herbal extracts
- Product Listing: We manage the listing and follow-up of food products in the SFDA system.
- Label Evaluation: We evaluate and modify product labels as necessary to ensure compliance with SFDA standards.
5. Cosmetics/ Perfume:
- Product Listing: We manage the listing of cosmetic products and provide a range of related services.
- PIF Preparation: We prepare the Product Information File (PIF) and ensure label compliance with SFDA regulations, including restricted and prohibited items.
- Product Evaluation: We evaluate cosmetic products to ensure they meet SFDA standards and regulatory requirements.
6. Health product:
- Evaluation of the documents, requirements and registeration of the products
7. Herbal product:
- Evaluation of the documents, requirements and registeration of the products
Our Partners
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Pharma United
LaVida Health
