Pharmaceutical
eConsulting
Pharmaceutical eConsulting (PeC)
Since 2007, Pharmaceutical eConsulting has worked to simplify and strengthen the way life science organizations manage regulatory submissions. Our mission is to help companies deliver compliant, efficient and reliable submissions across all global markets while maintaining full control, transparency and quality. With more than 18 years of experience, PeC has supported 100+ pharmaceutical and biotechnology clients worldwide and delivered more than +30000 eCTD sequences to health authorities including EMA, FDA, Health Canada and many others. Our work combines technical precision with strong communication. We believe that effective collaboration and clarity are just as important as technical competence. That is why PeC builds partnerships that make complex regulatory operations easier, faster and more predictable for our clients.
Employees
Branches in different countries
Submissions
Experience and expertise
PeC is headquartered in Copenhagen with offices in Boston, San Francisco and Bangalore, ensuring time zone coverage and efficient coordination for international projects. Our team consists of around twenty highly experienced specialists, many with more than +25 years of experience in Regulatory Affairs and Quality Assurance. This deep industry knowledge allows us to understand both the strategic and operational realities of regulatory work from dossier compilation and submission management to the ongoing maintenance of product registrations. Our people are not just technical experts they are communicators who understand the importance of consistency, traceability and alignment with internal client processes. Every project is managed with the same goal to make our clients’ regulatory activities run smoothly, efficiently and with full compliance to agency requirements.
Regulatory excellence
PeC’s core expertise lies in the preparation, compilation, validation and management of electronic submissions. We have worked with all common formats including eCTD, NeeS and paper, supporting submissions to major global authorities as well as regional and local markets. Our team operates under a disciplined quality framework that ensures precision and reliability at every step. Each submission sequence is validated in three independent validation tools, with the goal of achieving total error free validation reports for complete confidence before delivery. In addition, every sequence undergoes an internal peer review by a second PeC specialist prior to client review. This practice ensures the highest quality standards and reduces the time clients need to spend on internal review and approval.
This structured, quality controlled approach has made PeC a trusted partner for companies seeking to maintain flawless compliance and dependable performance in their regulatory operations.
Process and communication
At PeC, communication is a defining element of our work. We keep clients informed at every stage, providing clarity on timelines, validation status and document readiness. Our approach is transparent, collaborative and proactive, designed to minimise uncertainty and ensure that our clients always know exactly where their submissions stand. We understand that effective regulatory work depends on more than just meeting technical standards. It also depends on coordination between teams, consistency of data and alignment with internal processes. PeC’s experience in managing complex, multi regional projects means we can act as an integrated part of each client’s regulatory operation, ensuring smooth workflows and reliable outcomes.
Our values
Quality and precision. Every submission is prepared, validated and delivered to the highest standards. Transparency. All processes, validation results and metrics are traceable and measurable. Communication. We keep dialogue open and proactive to avoid bottlenecks and surprises. Flexibility. We adapt to each client’s systems, templates and internal processes. Commitment. We treat each submission with the same care and responsibility as if it were our own.
Global perspective and local commitment
With offices in Europe, North America and Asia, PeC provides the advantage of both global reach and local understanding. Our international structure allows us to support clients efficiently across multiple time zones and regulatory regions, while maintaining the personal contact and accountability that characterize a smaller, specialized company. We take pride in combining precision, reliability and communication into one seamless service, ensuring that every submission is not only compliant but also delivered efficiently and confidently.
US regulatory representation
For non United States based companies, PeC can act as the official United States Agent in accordance with FDA regulations. Through our offices in Boston and San Francisco, we provide a compliant and responsive communication channel between our international clients and the US Food and Drug Administration. As US Agent, PeC ensures that all correspondence, submissions and regulatory notifications are managed in accordance with 21 CFR requirements. We assist our clients with the maintenance of establishment registrations, the coordination of submissions and prompt handling of FDA inquiries. Our presence in the United States provides a reliable and fully compliant bridge for non US companies that require representation for their marketed products or pending applications. This service is supported by the same level of precision, transparency and responsiveness that defines all of PeC’s operations.
Our promise
PeC’s promise is simple. To make complex regulatory submission processes clear, compliant and efficient. To act as a dependable partner that clients can trust with their most important deliverables. And to ensure that every submission is handled with the highest standard of quality, accuracy and care.
Our values
Quality and precision. Every submission is prepared, validated and delivered to the highest standards. Transparency. All processes, validation results and metrics are traceable and measurable. Communication. We keep dialogue open and proactive to avoid bottlenecks and surprises. Flexibility. We adapt to each client’s systems, templates and internal processes. Commitment. We treat each submission with the same care and responsibility as if it were our own.
Global perspective and local commitment
With offices in Europe, North America and Asia, PeC provides the advantage of both global reach and local understanding. Our international structure allows us to support clients efficiently across multiple time zones and regulatory regions, while maintaining the personal contact and accountability that characterize a smaller, specialized company. We take pride in combining precision, reliability and communication into one seamless service, ensuring that every submission is not only compliant but also delivered efficiently and confidently.
US regulatory representation
For non United States based companies, PeC can act as the official United States Agent in accordance with FDA regulations. Through our offices in Boston and San Francisco, we provide a compliant and responsive communication channel between our international clients and the US Food and Drug Administration. As US Agent, PeC ensures that all correspondence, submissions and regulatory notifications are managed in accordance with 21 CFR requirements. We assist our clients with the maintenance of establishment registrations, the coordination of submissions and prompt handling of FDA inquiries. Our presence in the United States provides a reliable and fully compliant bridge for non US companies that require representation for their marketed products or pending applications. This service is supported by the same level of precision, transparency and responsiveness that defines all of PeC’s operations.
Our promise
PeC’s promise is simple. To make complex regulatory submission processes clear, compliant and efficient. To act as a dependable partner that clients can trust with their most important deliverables. And to ensure that every submission is handled with the highest standard of quality, accuracy and care.