Services - Therainnova

Our Services

We give shape and form to our client's work by simplifying any complicated procedure.

Strategic Regulatory Advice
Marketing Authorisation Applications
Interactions with Health Authority
Due Diligence Processes
Interim Head of Regulatory Affairs
Submission Management
Regulatory Intelligence
Partnering with Industry Experts

Strategic Advice

Strategic Regulatory Advice and Regulatory Intelligence:

Throughout all phases of development

We advise and assist clients from early to late-stage development and provide strategic and operational support on small molecules, biologicals and biosimilars across a wide range of therapeutic classes. Here are areas of support that we provide:

1. Guidance on relevant legislation, guidelines and requirements in Europe and Switzerland within the respective therapeutic area

2. Strategic guidance on how the regulatory framework impacts our clients` product development towards filing a Marketing Authorization Application (MAA) in Europe including Switzerland

3. Provision of tailored regulatory roadmaps helping to maximize opportunities to accelerate and expediate development including provision of strategic advice on

SME advantages (support for micro, small and medium-sized enterprises)

Scientific Advice Considerations

PRIME (PRIority Medicines)

Parallel Advice EMA - FDA

Paediatric Investigational Plans (PIPs)

Orphan Designation Applications

Product Claims and Product Labelling

Clinical trial applications

4. Identify strengths and weaknesses of our client`s development program including opportunities to enhance the regulatory packages

Marketing Authorisation Applications:

EU, Switzerland,
and internationally

We advise our clients to successfully submit Marketing Authorisation Applications (MAA) in EU, in Switzerland as well as internationally through Project Orbis or Access Consortium

Perform gap analysis prior to MAA submissions

Advise on the filing pathway and MAA filing strategy for EU and Switzerland

Advise on international filing opportunities (such as Project Orbis / Access Consortium)

Assist in the preparation of a high quality and robust MAA dossier

Advise, guide and assist in any Health Authority interaction during pre-submission phase, MAA review and completion of MAA

Providing additional support throughout the post-approval phase, such as assistance with maintaining the MAA and navigating any changes in regulatory requirements

Partnering with other industry experts to provide a comprehensive MAA service package that addresses all aspects of the MAA process

Offering a dedicated point of contact to provide personalized support throughout the entire MAA process

Due Diligence Processes:

Increase the value package

We provide regulatory due diligence support to help clients identify potential risks and opportunities in potential acquisitions or partnerships.

Our regulatory experts review product development plans, health authority interactions and registration submissions to assess compliance with relevant regulations and identify areas for improvement

We provide recommendations for addressing any identified gaps or challenges, including strategies for accelerating development, addressing regulatory hurdles, or improving product labelling and claims

By offering these services, we help clients increase the value of their product portfolio and make more informed decisions in the due diligence process

Interactions with Health Authority:

Advise, influence and manage

We advise, influence, and manage interactions between our clients and health authorities. We provide support in the following areas:

Support for micro, small and medium-sized enterprises

Scientific advice considerations

PRIority Medicines (PRIME)

Parallel advice between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)

Paediatric Investigational Plans (PIPs)

Orphan designation applications

Product claims and labelling

Clinical trial applications

Post-approval support

Pre-MAA activities, interactions during MAA review and closeout

Interim Management

Serve as interim Head of Regulatory Affairs:

For companies that do not require a full-time employee or have a vacancy in the role, act as the interim Global Head or Head of the Regulatory Department

Partnering with Industry Experts:

Partnering with other industry experts to provide a comprehensive service package during drug development and for MAA submissions that addresses all aspects of the regulatory process

Submission Management

Provide operational support:

Our submission management services include operational support for MAA submissions, coordination and oversight of the entire MAA process, and project management from start to approval. We also offer support for SMEs and assist with several types of scientific advice, paediatric investigational plans, and orphan drug designation applications. The operational services include:

Support for micro, small and medium-sized enterprises (SME)

Scientific advice

PRIority Medicines (PRIME)

Parallel advice between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)

Paediatric Investigational Plans (PIPs)

Orphan Designation applications

Product claims and labelling

Clinical trial applications

Post-approval support

Project Management of the MAA process from start to approval