Registration services offer
CanPoland supports pharmaceutical companies in the registration process of pharmaceutical raw materials. We provide comprehensive regulatory support, minimize procedural risk, and shorten the time to market.
Your partner in registration processes
„Our goal is to effectively guide clients through the registration process, minimize procedural risk, and shorten the time it takes to bring the product to market.”
Scope of services
Comprehensive registration of the raw material in the Office for Registration of Medicinal Products
- Documentation analysis and identification of deficiencies.
- Preparation of a dossier in accordance with the requirements of the Office for Registration of Medicinal Products.
- Submitting an application and communicating with the office.
- Coordination of the entire procedure.
Registration on behalf of the client
- Full representation before the Office for Registration of Medicinal Products.
- Conducting the process as a responsible entity.
Change of MAH / transfer of responsibility
- Preparation of documents.
- Coordination of formalities and updating of data at the Office for Registration of Medicinal Products.
Documentation audit
- Assessment of compliance with Ph. Eur. 3028, GMP/GACP.
- Identification of gaps and recommendations for action.
Preparation of a complete dossier
- Development of quality and administrative modules.
- Ensuring consistency and completeness of documentation.
Responses to inquiries from the Office for Registration of Medicinal Products and post-registration updates
- Quick and substantive responses to calls.
- Minimizing the risk of delays.
- Introducing qualitative and formal changes after registration.
Regulatory consultations
- Advice on GACP, GMP, European Pharmacopoeia and requirements of the Office for Registration of Medicinal Products.
Do you need an individual approach or additional service?
Let's talk about your needs →Step-by-step registration process
Initial consultation
Analysis of customer needs and identification of the optimal registration path.
Documentation audit
Assessment of compliance with Ph. Eur. 3028, GMP/GACP. Identification of deficiencies and recommendations for action.
Preparation of the dossier
Development of quality and administrative modules. Ensuring consistency and completeness.
Submitting an application
Submitting an application to the Office for Registration of Medicinal Products, communicating with the office and monitoring its status.
Post-registration support
Obtaining an approval decision. Introducing qualitative and formal changes after registration.
Key benefits for the customer
Faster product launch
Collaborating with CanPoland significantly accelerates the registration process by eliminating procedural errors, utilizing standardized work methods, and understanding practical interpretations of regulations. The team's experience allows them to prepare documentation in line with the Office for Registration of Medicinal Products' expectations on the first attempt.
Obtaining permit decisions much fasterFinancial and operational savings
Outsourcing registration processes eliminates the need to build an in-house regulatory department, invest in training, or maintain specialized infrastructure. Service costs are predictable, and the risk of costly rework is significantly reduced.
Lower operating costs by up to several dozen percentAccess to specialist knowledge
Clients gain access to a team of experts in quality, pharmacy, chemistry, and regulatory affairs, experienced in projects involving pharmaceutical raw materials and herbal APIs. Continuous monitoring of regulatory changes and knowledge of GACP, GMP, and European Pharmacopoeia requirements guarantee the highest level of substantive documentation.
Minimizing the risk of application rejection
A well-prepared, complete, and consistent dossier significantly reduces the risk of requests for supplementation and application rejection. Eliminating formal errors and prompt, professional responses to regulatory inquiries increase the chances of a positive decision at the first assessment.
Maximizing the chances of a positive decision already at the first assessment of the documentationRelieving the team and focusing on key activities
By taking over full communication with the Office for Registration of Legal Advice and handling formalities, CanPoland allows clients to focus on production, sales, product development, and strategic activities. This allows internal resources to be used more efficiently.
Scalability and flexibility of collaboration
Regulatory services are available exactly when needed, without the need for a permanent team. This allows for the management of multiple projects in parallel, without the need to expand internal structures or generate unnecessary costs.
Professional representation before the Office for Registration of Medicinal Products
CanPoland provides comprehensive correspondence management, deadline monitoring, application status monitoring, and recommendations for optimal regulatory strategies. This ensures smooth and predictable relations with the regulator.
Higher quality documentation
The documentation prepared by CanPoland is consistent, complete and precise, which facilitates its evaluation and builds the professional image of the organization.
A well-prepared dossier increases the chances of a smooth completion of the procedure