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Fischer Chemicals offers comprehensive and competent collaboration: from the API, medical devices to medicinal products authorisation, from procuring raw materials up to entire regulatory services.

Today’s rapid developments in science and technology coupled with constantly growing regulatory framework for active ingredients and medicinal products, demands excellence in screening the abundance of directives and guidelines applying to DMF/CEP and registration dossiers. Our strength is to generate these registration dossiers in accordance with requirements or adapting existing documents.

The right strategy for compilation and submission in consultation with the authorities is vital for timely market approval of active ingredients and medicinal products. On request we will support the submission of the approval dossier for your developed active ingredients or medicinal products to the relevant national or international regulatory authorities.

Overview of our services:

Strategy
• Evaluation of regulatory procedures to achieve best possible
registration outcome

Management
• Project management: planning, monitoring and leadership
• Critical path analysis for products
• Submission planning
• Assistance for audits preparation and support during inspection

Evaluation
• Expert review including regulatory gap analysis and dossier validation

Development
• Assistance in preparation
• Review of product development in respect to pharmaceutical,
pharmaco-toxicological and clinical aspects

Preciseness
• Suitability Reviews of acquisition, co-marketing and licensing
opportunities and company acquisation

Documents
• Clinical trail and marketing applications (MAA’s via mutual
recognition decentralized and centralized procedure)
• Certificate of suitability (CEP) procedure
• CTD formats

Network
• Contact and communication with regulatory authorities
• Interpretation of regulatory agency’s statements
• Agency meetings
• Responses and submission of applications to regulatory agencies