Review of the dossier according to local requirements. 

Preparation of checklist on provided and missing documents.

Dossier pre-submission assessment / gap analysis is a key activity in product registration. It reduces risk of rejection, avoid/minimize deficiency letters and accelerate approval process.

A regulatory strategy is a foundational document that clearly outlines the critical regulatory pathways and objectives to ensure adequate planning to bring a new product to market, identifies any potential challenges and offers solutions or alternative approaches to new product registration or product lifecycle management.

A limited or inadequate strategy can challenge global expansion and inplementation of required business needs, thus emphasizing the importance of a well-designed and executed regulatory strategy.

Review/preparation of documents according to country specific requirements. Organization of translation of documents to local language (if required). Compiling the dossier for submission. 

Registration of Medicinal products, Food Supplements, Medical devices according to National and EAEU procedures. 

The registration process includes full procedure management: 

• Core dossier gap analyses for compliance with local requirements;
• Pre-compiling of submission dossier (including, but not limited to preparation of local administrative documents and updating of PIL, SmPC, Labelling); 
• Filing of the dossier and samples to local Health Authority;
• Managing payments of state fees;
• Communication with Health Authority Experts throughout whole registration process from submission till approval;
• Receiving defficiency letters (DLs), providing assistance with preparation of response to DLs. 
• Tracking and monitoring of private applicant cabinet at Health Authority platform; 
• Finalization of process. Obtaining/review of approved documents.

We specialize in renewing Marketing Authorizations for Medicinal products, Food Supplements, and Medical devices through National procedures. Our comprehensive service covers every aspect of the renewal process:

• Conducting thorough gap analyses of core dossiers to ensure compliance with local requirements.
• Preparing and compiling submission dossiers, including the preparation of local administrative documents and updating of PIL, SmPC, and Labelling.
• Submitting dossiers and samples to the local Health Authority.
• Managing the payment of state fees.
• Maintaining open communication with Health Authority Experts throughout the entire registration process, from submission to approval.
• Handling deficiency letters (DLs) and providing assistance in preparing responses.
• Monitoring and tracking the private applicant cabinet on the Health Authority platform.
• Finalizing the process and obtaining/reviewing approved documents.

Changes to the dossier for Medicinal products, Food Supplements, Medical devices according to National and EAEU procedure. The variation process includes full procedure management:

• Determining the type of variation according to local legislation and providing list of documents required for submission.
• Variation dossier gap analyses for compliance with local requirements;
• Pre-compiling of submission dossier (including, but not limited to preparation of local administrative documents and updating of PIL, SmPC, Labelling);
• Filing of the dossier and samples to local Health Authority;
• Managing payments of state fees;
• Communication with Health Authority Experts throughout whole registration process from submission till approval; 
• Receiving defficiency letters (DLs), providing assistance with preparation of response to DLs.
• Tracking and monitoring of private applicant cabinet at Health Authority platform;
• Finalization of process. Obtaining/review of approved documents.

Bringing the Dossiers into Compliance with the Eurasian Economic Union (EAEU) rules for all medicinal products that were previously authorized among EAEU member states according to their national rules.

Preparation of country specific Normative document for quality control of finished product, based on core dossier. Update/review of provided Normative document for quality control of finished product in accordance with local requirements.

Review of artworks according to local legislation/approved documents. Assistance with preparation of artworks ensuring linguistic accuracy and Regulatory compliance.

Translation of the dossier to local language. Proofreading of translated documents by our experts.

Preparation of regulatory intelligence table with all main information according to local legislation and our excessive experience. Providing information regarding potential or actual legislation updates immediately after it’s being known/coming into force.

Providing additional information and response to Client’s questions regarding legislation/ local requirements and strategic advice on submission.

Converting the dossier to XML format for EAEU submissions as well as validation of the dossier for errors, which minimizes the risk of returning the dossier to the regulator.

A thorough review of the text and layout of the product information leaflet, questionnaire and protocol development, recruitment of participants, performing pilot test and full test, preparation of complete report. 

Coordination of all strategic efforts needed for a successful market release.