Scientific writing: CTD
Famar’s Regulatory Affairs experts compile medicinal product quality information in the CTD format for submissions on behalf of their customers and marketing authorization holders.
Regulatory affairs specialists provide advice, technical scientific due diligence of registered dossiers for quality and completeness, prepare and review dossiers and keep them up-to-date at all times according to thecurrent legislation.
Famar’s services include:
1. Marketing authorization dossiers for human medicinal products (CTD modules 2.3 and 3)
— Module 2.3 contains the table of contents and summaries of module 3
— Module 3 contains information about pharmaceutical quality (quality dossier)
2. Planning, preparing, updating, reviewing and reformatting of quality dossiers
3. Reformatting CTD to eCTD
Technical writing: Non-pharma products (cosmetics, Biocides, Medical Devices, Food Supplements)
Organizing customer’s data and other technical information for their cosmetics (PIF), Biocidal products, Medical Devices (Technical dossier) and Food supplements will help them maintain their product in Europe while meeting the European market requirements.
Famar’s Regulatory Affairs team will compile in specific templates the technical data sheet and/or specifications and all the quality related information for its customers’ products.
1) Regulatory Gap Analysis
A regulatory gap analysis is the comparison of two dossiers either of medicinal products (Module 3 vs Module 3) or of non-medicinal products. Famar’s regulatory affairs team will assist in flagging gaps and identifying differences between two or more regulatory dossiers and tailor the regulatory gap analysis according to the customers’ needs and intended scope.
Apart from the preparatory work and delivery, this service entails step-by-step teleconference meetings for explanations and questions.
2) Compliance Gap Analysis
A compliance gap analysis is the comparison of the current manufacturing and testing practices versus the currently registered and approved dossier of the product. A tailored template designed by Famar’s Regulatory Affairs team will flag in detail all the gaps. Proposed actions in order to remediate the gaps
are included in the same template.
A Variation Registry Card can be prepared as an additional service according to the client’s needs to demonstrate the variations that need to be submitted for the gap remediation in case of regulatory impact.
3) Transfer gap analysis (NPIs)
There is no better way to initiate a New Product Introduction than to perform a Technology of Transfer gap analysis. Famar’s Regulatory Affairs team provides to its customers the guidance to take all the necessary steps in order to capture in one file everything which is needed for their product.
The template consists of separate segments to represent the donor site information, the currently registered and approved (regulatory) information and the proposed practices in all fields of the quality part of the dossier (formula, manufacturing, analytical, packaging and stability).
Gaps are identified and proposals are depicted within the same template.
A Variation Registry Card can be prepared as an additional service according to the client’s needs demonstrating the variations that need to be submitted in order to close the gaps in case there is regulatory impact.
Constant consultation and presence of the Regulatory Affairs team is possible to be provided as a separate service in case of different CMO is applicable.
Regulatory Affairs Submission Strategy
“To improve is to change; to be perfect is to change often” and this is very applicable in the pharmaceutical world. Changes, however, lead to variations and submissions of new dossiers. A regulatory/submission strategy will always safeguard Famar’s clients with the authorities’ requests and needs. For any change they want to perform to their product, Famar’s Regulatory Affairs team will prepare a Regulatory Submission Strategy Proposal. The RA team will identify the type and the number of the variations needed, flag potential pitfalls and conditions and identify the appropriate documentation (CMC and extra documents) required to be submitted.
Follow-up until approval by HA and help to respond in requests and Deficiency Letters
For any quality related extra requests or responses to Deficiency Letters with regards to quality matters, Regulatory Affairs team’s expertise, and broad network of experts within Famar, will assist its customers to overcome any additional authority request.