Pharmaceutical Documentation
Navigating the complex documentation requirements for pharmaceutical product registration across global markets.
While regulatory requirements vary by country, most markets share common documentation standards to ensure pharmaceutical products meet rigorous efficacy, safety, and quality benchmarks. At Sovvaka Global, we guide you through these requirements to facilitate smooth market entry.
Essential Documentation
Understanding the critical documentation required by regulatory authorities worldwide for pharmaceutical product registration.
Good Manufacturing Practices (GMP) Certificate
Official certification confirming that a manufacturing facility meets WHO-established quality standards following rigorous regulatory inspection.
Certificate of Analysis (COA)
Detailed document verifying that a product batch meets all quality specifications according to the relevant pharmacopoeia, including test parameters and results.
Certificate of Pharmaceutical Product (COPP)
Legal document confirming that a product is approved for sale in its country of origin, often required by foreign regulatory authorities during registration.
Free Sales Certificate (FSC)
Official document listing multiple pharmaceutical products authorized for commercial distribution in domestic and international markets.
Product Registration Dossier
Comprehensive technical documentation detailing all aspects of product development, manufacturing, quality control, and stability studies.
Registration Certificates
Proof of successful product registration in other markets, often requested to facilitate approval in new territories.
Product Registration Dossier
The Product Registration Dossier is a comprehensive technical document that forms the cornerstone of the registration process, providing regulatory authorities with detailed information about every aspect of a pharmaceutical product.
Raw Materials & Ingredients
Detailed information on the origin, specifications, testing procedures, and quality control of all active pharmaceutical ingredients (APIs) and excipients used in the formulation.
Manufacturing Process
Step-by-step description of the production process, including flow diagrams, critical control points, in-process controls, and validation procedures to ensure consistent quality.
Quality Control
Comprehensive analysis of the final product according to pharmacopoeial standards, including detailed test methods, specifications, and acceptance criteria.
Stability Studies
Short and long-term stability data demonstrating that the product maintains its quality, efficacy, and safety throughout its proposed shelf life under various environmental conditions.
Documentation Process
Our systematic approach to pharmaceutical documentation ensures compliance with regulatory requirements across diverse global markets.
Requirements Analysis
01We analyze the specific documentation requirements for each target market, identifying similarities and differences to create an efficient preparation strategy.
Document Preparation
02Our experts prepare all required documentation according to local regulatory standards, ensuring accuracy, completeness, and compliance.
Technical Review
03Each document undergoes rigorous technical review to verify scientific accuracy, consistency, and alignment with product specifications.
Regulatory Review
04Our regulatory specialists review all documentation to ensure compliance with current regulations and guidelines in the target market.
Authentication & Legalization
05When required, we manage the authentication and legalization process for documents through relevant government agencies and embassies.
Submission & Follow-up
06We coordinate the submission of documentation to regulatory authorities and provide follow-up support to address any queries or requests for additional information.
Benefits of Our Documentation Services
Our comprehensive documentation services provide numerous advantages that streamline the product registration process and facilitate market access.
- Accelerated market entry through expertly prepared documentation
- Reduced risk of regulatory rejection or delays due to documentation issues
- Cost-effective approach through standardized documentation templates adaptable to multiple markets
- Expert navigation of complex and evolving regulatory requirements
- Comprehensive support from document preparation to submission and follow-up
- Continuous updates to documentation in response to regulatory changes
Need Help with Documentation?
Contact our documentation experts today to discuss your specific requirements and discover how we can streamline your product registration process across global markets.
Our Documentation Expertise
- Common Technical Document (CTD) preparation
- Product dossier development
- Certificate acquisition and authentication
- Regulatory submission management
- Multi-market documentation strategies