We provide scientifically based strategic and operational support and advice to companies and academia from early research throughout the product lifecycle.

As part of your project team, we use our ex-regulator and drug development experience to analyse current regulatory thinking, the regulatory precedence together with the scientific data. We provide regulatory and scientific expertise in all areas of drug development (preclinical, clinical and pharmaceutical development).

We are senior regulatory advisors who can

  • Understand the dependencies between scientific, commercial and regulatory decisions
  • Apply current regulatory thinking in the context of the scientific opportunities in the individual project
  • Be part of the development team and bring regulatory aspects to the table
  • See the regulatory challenges and opportunities in drug development


Target product profile

Successful drug development begins with keeping the end in mind! Start your development journey by developing the Target Product Profile, TPP. The product shall meet the expectations of patients, payer, prescribers, and the relevant regulatory requirements. The aim of the TPP is to describe the product attributes that will fulfill those requirements. It is especially important to define the medical and market needs. We will help you to develop the TPP, and keep it updated as data emerges.



Global regulatory strategy

We will help you build a regulatory strategy integrated in your product development plans to support EU and US approval and market entry.

A regulatory strategy is an important tool to help navigate the complex regulatory landscape and ensure that the product meets the necessary requirements for market authorisation and market needs. By including regulatory aspects early on in the project time to market will be minimized.

Regulatory requirements may differ across countries or regions, the plan should be tailored to the company’s unique circumstances and objectives. Additionally, regulatory plans should be regularly reviewed and updated as new data emerges, regulatory landscapes evolve, or when new products or markets are introduced.

We believe that progress in research and development comes from teamwork, and we are committed to bringing the regulatory aspects to the table. We will analyse the regulatory environment and precedence, scientific data and current regulatory thinking. We assess preclinical, clinical and CMC data and development plans from a regulatory perspective, identifying opportunities and issues and provide a regulatory strategy moving forward.


Drug development expertise

Important decisions taken early in the development process can have a big impact on the regulatory route. This is where we really see what difference we can make for your business. These initial discussions are those that will make the biggest impact on the success of your drug product development strategy and your business.

By having a detailed understanding of your product target product profile and by getting the understanding of what your product can do for helping the patients and users, we will guide you through the regulatory requirements and the work needed to put different possible types of your product on the market.

With this input, you will understand how to strategically plan your development program.

We provide scientific drug development expertise in:
  • Development of target product profile (TPP)
  • Drug substance and drug product development with experience from a broad range of drug substance classes and dosage forms
  • Support in development of a regulatory CMC strategy including e.g drug substance/product classification, starting material strategy, formulation strategy, bridging strategy, stability strategy, impurity control strategy, and validation strategy
  • Nonclinical strategy including design of nonclinical studies
  • Clinical development strategy including clinical study design with experience from major therapeutic areas, such as CNS, cancer, diabetes, rare diseases
  • Clinical pharmacology, pharmacokinetics, pharmacometrics and drug-drug interactions



The RegSmart view on “Regulatory”

All projects are different, and there are rarely any standard solutions to the challenges in product development. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the individual project. We can assist in identifying opportunities, challenges and risks associated with the drug development program, and help to develop mitigation strategies.

Our advisors are experienced in interpreting the global regulatory framework from a scientific and business perspective with specific focus on the EU and US markets. We also have insight and experience in regulatory requirements for other geographical areas.

We will help you look into the future and predict in what direction regulations heading.


The regulatory toolbox

There are many tools in the regulatory toolbox, we will help you find the ones suitable for your product and geographic area (US and EU):

  • Planning, preparation, application and participation in regulatory interactions such as FDA pre-IND, and EoP2-meeting as well as national and centralized EU scientific advice
  • Regulatory, incentives
  • Paediatric investigational strategy and application
  • Orphan drug strategy and application
  • Advice on potential use of regulatory pathways to support innovative products, e.g PRIME (EU) and Breakthrough Designation (US)
  • Small and medium-sized enterprise (SME)-status, information about benefits and qualification requirements




RegSmart provides support to clients to fulfil post-approval pharmacovigilance (PV) requirements. We offer strategic advice in development of pharmacovigilance systems, including pharmacovigilance System Master File (PSMF), to obtain a system that is fit-for-purpose based on needs, and in compliance with regulatory requirements.

We all know the importance of reporting adverse events of medicinal products. But this is just one part of the pharmacovigilance system.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Marketing authorisation holder (MAH) is obliged to have a pharmacovigilance system in place to monitor the safety of their authorised medicinal products. This system shall be described in a Pharmacovigilance System Master File (PSMF). At the time of initial MA application (MAA), the applicant is required to set up a pharmacovigilance system that should be in place and functioning at the time of granting of the market authorisation (MA).

Therefore, start planning and preparing for your pharmacovigilance system in time for your MA application!

With long experience from pharmaceutical industry, government inspections and expertise in pharmacovigilance legislation, we can perform audits of marketing authorisation holder (MAH), partner companies and service providers to identify GAPS in the pharmacovigilance system.

At RegSmart, we are ready to support you with:

  • Pharmacovigilance Audits
  • Strategic planning and advice in establishment of a new pharmacovigilance system including PSMF expansion of an existing Pharmacovigilance-system – e.g., after purchase of new products or company mergers
  • Inspection readiness
  • Implementing the Pharmacovigilance system into your quality system, including quality control of SOPs.
  • Assignments as Qualified Person for Pharmacovigilance (QPPV) – and deputy QPPV / in situations with need of extra staffing e.g., long-term absence or lack of qualified personnel
  • Training in Pharmacovigilance
  • Advice in establishment of Safety Data Exchange Agreements