Regulatory Liason

Franciosi Consulting Ltd. can advise or represent the Client during dialogue with regulatory authorities, both within the EU and Canada. SMEs in particular will find this service invaluable to create a strategy fit for purpose and avoid common problems in the development process. Additionally, Franciosi Consulting’s regulatory network is able to support applications in central Europe (CEE and CIS countries).

Document Preparation and Evaluation

Franciosi Consulting has extensive experience in preparing review documents for use by in-house project teams as well as Investigator’s brochures (IB), Common Technical Documents (CTD), Investigational New Drug applications (IND) and Investigational Medicinal Produce Dossiers (IMPD) for regulatory submission. Franciosi Consulting has well established and tested QC and verification procedures and is compliant with the Copyright Licensing Agency. In-licensing and out-licensing of drugs in early development is a major feature of the pharmaceutical industry and requires a thorough and competent review of the data. Franciosi Consulting will assess the nonclinical dossier for completeness, technical competence and scientific and regulatory content and provide the Sponsor with an assessment of any likely issues and data gaps.

Consultant Networks

Drug development is a complex, multi-disciplinary process. Franciosi Consulting has a wide network of independent associates already under CDA to assist when questions arise outside this service’s core areas of expertise.

Business Improvement

Franciosi Consulting regularly provides lectures and training presentations in key areas of regulatory safety evaluation. Training is based on practical experience as well as recent publications. All presentations are adapted to your company’s needs and are valuable to companies looking to improve their business. These include: – Evaluation of a company, division or department with the aim of improving efficiency – Advice on business opportunities in niche markets – Critical, independent evaluation of facilities as a part of due diligence prior to merger or acquisition – Advice on setting up inhalation test laboratories in accordance with GxP: Specifications and equipment Documentation, guidelines and SOPs Staff education and training

Strategic Advice

This service is aimed primarily at pharmaceutical companies who are active in the areas of discovery or formulation but require assistance in the drug development process. A major part of this service is the design and implementation of regulatory and scientific strategy for preclinical programmes and early stage clinical studies. Franciosi Consulting has extensive experience in outsourcing to CROs and dealing with a variety of skill-sets within academia in connection with pharmacodynamics, safety evaluation and ADME.

CRO Selection and Monitoring

Franciosi Consulting’s considerable experience of the pharmaceutical and CRO industry make Franciosi Consulting ideally placed to advise pharmaceutical companies on selection of appropriate CROs. This service’s current-awareness of CRO skills and costs enables Francisosi Consulting to provide cost-effective placement of preclinical, early stage clinical, and bio-analysis studies. Franciosi Consulting has extensive practical experience and so is ideally placed to provide CRO monitoring to support in house resources. A report review service is part of this service. A lack of internal resources to review CRO reports promptly is common and this service has expanded its internal resource to ensure CRO reports are reviewed and finalized promptly.

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