Regulatory Strategy & Implementation

Regulatory has been the core of our business from the start, and over the years we've developed an experienced team who pride themselves in helping clients not only with strategy, but also with implementation, a key component to successful commercialization.

Regulatory Strategy & Management of Drug Development

• Provide regulatory advice in the early phases of development projects
• Define the product’s concept
• Interpret regulations and guidelines
• Develop strategies for technical aspects of drug development (quality, pre-clinical, and clinical)
• Design and manage drug development programs
• Determine market access requirements and develop strategies in the early phases
• Identify and manage external resources/experts

Regulatory Strategy

• Evaluate technical data (chemistry/manufacturing, pre-clinical, and clinical) to help determine the appropriate regulatory procedure and legal status of products
• Actively consult with regulatory authorities for scientific advice (protocol assistance for orphan drugs)
• Arrange and manage scientific advice meetings with regulatory authorities
• Propose optimal filing and submission strategies
• Establish frequent contact with regulatory authorities to facilitate compliance

Regulatory Management & Implementation

• Clinical trial applications
• Dossier preparation (CTD, eCTD)
• Translation services
• Submission processes
• Liasion with health authorities
• Marketing authorization applications, procedural management, and marketing authorization holdership
• Post-approval maintenance
• Variations, renewals, pharmacovigilance, and PSURs
• Technical expert services

Rx to OTC Switches

• Development of strategy to ensure national switches are planned and implemented to an international standard
• Preparation of dossiers with full justification
• Evaluation of the impact of reclassification on product reimbursement and pricing
• Planning and implementation of parallel switches in multiple countries

Borderline Products

These days, an increasing number of products must be characterized as borderline, an ambiguity that exists due to either innovative products that don’t fall under prospective regulations or overlaps in existing regulations.

Our services in this field include:

• Demarcation and identification of appropriate regulatory paths with applicable legislation
• Development of optimized regulatory strategies aimed to achieve marketability
• Intermediation and close interaction with competent authorities, notified bodies, and other regulatory bodies in order to safeguard chosen strategies

Our fields of expertise are

• Medicinal products
• Medical devices
• Cosmetics
• Food and food supplements
• Dietary foods
• Foods for special medical purposes
• Any relevant borderline areas in between

Small Medium Enterprises - SMEs

EMA

The EU recognizes the key role that micro, small, and medium-sized enterprises (SMEs) play in innovating new medicines, and the benefits they provide for patients. At the same time, it acknowledges that SMEs don't have the same resources as larger companies. To mitigate this issue, the EU introduced financial and administrative help for SMEs in 2005.

We can assist companies who wish to achieve SME status and access its available incentives.

FDA

The Food and Drug Administration (FDA) is a large, complex organization that requires a solid grasp of which processes are relevant for which projects, and therefore requires very specific expertise for each separate product category.

In the US, we have access to experts who are competent in:

• Representing international companies as the designated US agent
• Liaising with the FDA to resolve issues and expedite market approvals
• Preparing and submitting drug establishment registrations/renewals and drug product listings
• Managing and inputting study information into the FDA database of investigational protocols for the treatment of serious and life-threatening diseases

Have a question concerning Regulatory Strategy or Implementation? Contact Beate Kienzler