Scientific Advice

Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Firstly, it ensures alignment with regulatory requirements, enhancing the likelihood of successful approval. Additionally, it facilitates early identification and resolution of potential regulatory hurdles, saving time and resources.

Our highly skilled Labmark experts can guide your project teams, write high-quality briefing books, and help you prepare for the meetings with EMA, FDA, or national agencies or attend them on the client’s behalf.

At Labmark, we assist you in interacting with necessary health agencies by guiding you through scientific advice and protocol assistance with EMA, FDA, and national agencies, as well as pre-submission meetings.

Types of scientific advice

An essential step in the early stages of developing a potential medicinal product of a candidate medicinal product is the preparation of the Clinical Trial Application for the First in Human (FIH) clinical trial.

Labmark’s experts will guide you through this process and subsequent steps, for example ensuring compliance with EU Pediatric Regulation Requirements, leveraging opportunities for Orphan Drug Status, and actively seeking regulatory authority input through Scientific Advice procedures throughout the development journey.

What does it entail?

Agency interactions

Successfully submit your application for drug approval to the competent authorities. Labmark we help you interact with the required agencies.

Preparation & communication 

Agency interactions play a central role in the drug approval process. For example, in the European Union (EU), a company that wishes to bring a pharmaceutical to the market must submit an application to the competent authority or the European Medicines Agency (EMA) for a ‘marketing authorization’ (license). 

Depending on the procedure, our team of experienced consultants help you to interact with all relevant health authorities: 

Centralized procedure: interaction with EMA, (co)-rapporteur, concerned member state. 
National, Mutual Recognition Procedure (MRP) and/or a Decentralized Procedure (DCP): interaction with national agencies.

How can we support

EC-REP - Regulatory Affairs - QbD Group (2)

How we support you

We offer a range of specialized services to support your interactions with regulatory authorities. From initiating contact to managing meetings, our experienced team ensures a seamless and effective approach throughout the entire regulatory process.

Initiate authority contact

We assist in establishing initial contact with regulatory authorities, ensuring clear communication and coordination from the start.

Prepare briefing packages

Our team prepares comprehensive briefing packages to support regulatory submissions and facilitate discussions with authorities.

Moderate authority meetings

We efficiently manage and moderate meetings with regulatory authorities, ensuring productive and transparent discussions.

Dossier (CMC) guidance

We provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) dossiers to meet regulatory expectations and ensure compliance.

Why partner with Labmark?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

Choosing Labmark means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.

10+ years of experience: benefit from our team of highly qualified consultants.
Full life cycle support: full support from pre- to the post-marketing phase.
Customer satisfaction: constant evaluation, transparency and clear objectives.