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Drug Regulatory Affairs

The challenges of drug regulatory affairs in a world of rapid change

In a rapidly changing world, drug regulatory affairs has become increasingly complex. Regional differences and rapidly changing regulatory requirements make regulatory submissions – especially when they involve different countries around the world – a challenging project.

Phact advises clients on regulatory issues throughout the (regulatory) life cycle of a medicinal product, whether in development, during or after marketing authorisation, whether small molecules or complex biotechnology products.

Phact specialises in the EU/EEA regulatory environment. Regulatory advice for other regions, in particular the United States of America (USA), Canada and Japan, is provided by Phact in collaboration with its regional partners.

Quality by Design (QbD) is a the concept of building (designing) quality into a drug product or drug substance. t has replaced the traditional empirical philosophy of ‘quality by trial and error’ with one of science and risk-based drug development.

As defined in ICH Q8, QbD is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management” (ICH Q8 (R2)).

We support our customers in introducing and implementing QbD, and in documenting the QbD approach in CTDs.

We look forward to hearing from you to discuss how we can best support you.

Choosing the best possible strategy to get a medicine approved becomes a key challenge and requires early planning.

In turn, an understanding of the regulatory environment is required to select the optimal regulatory strategy for a given drug product.

Phact specialises in EU regulatory affairs, helping clients develop optimal regulatory strategies for small molecule and biotech products seeking EU/EEA approval.

For other regions, namely USA, Canada and Japan, Phact works with regional partners to develop optimal registration strategies for customers.

Can we also support you with your project? We look forward to hearing from you.

In general, post-approval changes (PACs) to a once-approved drug product must be notified to the regulatory authority or even require prior approval before they can be implemented.

PACs are usually categorised as minor, moderate or major depending on the level of risk to public health and their potential impact on the quality, safety or efficacy of the product concerned.

Regional differences in procedures and requirements must be taken into account. Therefore, an understanding of the regulatory environment is required to select the optimal regulatory strategy for a given product.

Managing the post-approval regulatory change process for medicines on a global scale is complex and time consuming.

Phact has many years of experience in the preparation and submission of variation applications (as the PAC procedure is known in the EU) in both national (decentralised procedure, DCP; mutual recognition procedure, MRP) and centralised (CP) procedures.

For other regions we work together with regional partners to develop optimal registration strategies for customers.

Any questions or need assistance with your project? We look forward to hearing from you.

Whether during development or after approval, whether within or between companies, technology transfer is a complex project.

Successful technology transfer requires early planning, consideration of relevant regulatory activities (e.g. submission of a post-approval change request to the competent authority), clear responsibilities for both parties (sending and receiving) and professional management.

Phact has supported several technology transfers by providing regulatory advice, preparing scientific advice meetings with regulatory authorities and writing scientific and technical dossiers for submission.

Are you planning a technology transfer and need support?

Please get in touch if we can be of any assistance. We look forward to hearing from you.

The quality of the scientific-technical documentation is a key factor in the success of a submission project.

Well-structured and comprehensible technical and scientific information presented in a scientific style and clear format should be taken for granted when preparing the dossier to submit.

In addition, the resulting PDF files must be navigable and provide specific PDF-specific settings and properties when integrated into the eCTD.

Phact has extensive knowledge and practical experience of producing high quality technical documentation.

Can we also support you with your project? We look forward to hearing from you.

The Drug Master File (DMF) system allows confidential quality-related information to be submitted directly from the manufacturer of the drug substance to the regulatory authority(ies).

DMF systems exist in at least all major industrialised countries. However, there are regional differences in applicability and procedural aspects.

The EU Active Substance Master File (ASMF) procedure is limited to so-called “well-defined” active substances and follows an “open & closed parts” concept. The ‘closed’ (restricted) part of an ASMF contains confidential information. It is submitted directly by the active substance manufacturer to the competent authority(ies). Less sensitive information is sent to the MAH, i.e. the applicant, who integrates both the closed and open parts (which together form the ASMF) into the relevant quality sections of the CTD 3.2.S submission dossier.

An EU ASMF can only be submitted to the regulatory authorities in support of a marketing authorisation application.
Phact has many years of experience in the creation of ASMFs.

Do you need assistance with your ASMF? We look forward to hearing from you.

Regulatory meetings are a key element in planning for a successful submission.

Whether it is the preparation of briefing meetings for innovative products, scientific advice, or pre-submission meetings, Phact can help you to

  • Planning and organisation of regulatory meetings
  • Submission / review of briefing packages
  • Accompanying the regulatory meetings
  • Evaluating the outcome of the meeting and proposing actions to be taken.

Please contact us for further information.