Conventional small-molecule drugs, orphan drugs, biotechnological products and traditional herbal medicinal products

• Evaluation and reporting on dossiers of products for which filing a marketing authorization application is planned, in line with the current regulatory requirements and our experiences (GAP Analysis)
• Preparation of GMP/Marketing Authorization prioritization application dossiers, including a justification report
• Preparation of GMP inspection application dossiers
• Organization of GMP inspection processes
• Providing expert support to GMP inspections on behalf of companies
• Preparation of marketing authorization dossiers for prescription drugs, over-the-counter drugs and traditional herbal medicinal products in CTD format for electronic submission (including the XML file) in accordance with current regulatory requirements, and submitting dossier electronically upon request
• Preparation of analysis dossiers, including analysis requirements
• Completion of the BA/BE Form, submitted as part of the marketing authorization dossier, and preparation of the trial dossier in suitable format for application.
• Preparation of Type I and Type II variation applications and extension dossier and submitting these dossiers electronically upon request
• Preparation and update local SmPC & PIL
• Preparation of application dossiers for marketing authorization transfer and renewal
• Preparation of application dossiers for pricing
• Follow-up services on the official institutions and organizations

• Preparation of marketing authorization application dossiers in accordance with current legal requirements and guidelines
• Preparation of GMP inspection application dossiers
• Preparation of Type I and Type II variation application dossiers in accordance with current legal requirements and guidelines

• Registration of manufacturer and importer company
• Evaluation of declarations of conformity and EC certificates for eligibility
• Registration of required class-specific documents
• Preparation of the initial approval application for registration in UTS (Product Tracking System), and submission electronically
• Preparation and submission electronically of update applications for post-approval changes in the manufacturer or the product,
• Preparation and submission electronically of withdrawal applications
• Preparation of product catalogues
• Evaluation of labels, texts and artwork before launch for compliance with current legal requirements

• Registration of companies
• Registration of qualified persons
• Preparation and submission electronically of the initial approval application for registration in UTS (Product Tracking System)
• Preparation and submission electronically of update applications for post-approval changes in the manufacturer or the product
• Preparation of the Cosmetic Safety Assessment Report
• Preparation of the Product Information Dossier
• Evaluation of labels, texts and artwork before launch for compliance with current legal requirements

• Registration of manufacturer and importer companies
• Preparation of approval application dossiers for imported or locally manufactured FSs
• Preparation of the control certificate application dossier for FSs that subject to control certificate.
• Evaluation of labels, texts and artwork before launch for in accordance with current legal requirements
• Preparation of GGBS pre-notification and shipment notification submissions for post-approval market launch of imported FSs
• Preparation of physical inspection dossiers
• Preparation of Ministry Commission application dossiers for unlisted ingredients
• Evaluation of the compliance of ingredients prepared for formulation development with the regulations

• Preparation of application dossiers for Type I and Type 19 biocidal products

• Preparation of required application dossiers for Compassionate Use Programs
• Preparation of application dossiers for Programs for Post-Clinical Trial Access to Medicine
• Providing Due Diligence services