Pharmaceuticals – Regulatory

Strategic guidance for global compliance

Expert support for EMA, FDA, and international regulatory interactions.

CRONET provides strategic regulatory services to pharmaceutical companies developing human medicinal products. We support our clients in all phases of development, from early planning to regulatory submission, and ensure efficient communication with authorities such as EMA and FDA.

End-to-End Regulatory Support

CRONET supports its clients in assessing and advising on all aspects of regulatory strategy for product development and ensures compliance with global regulatory requirements.

We support you in interacting with authorities and preparing documents for global submissions, including:

Investigational New Drug (IND) and Investigational Device Exemption (IDE)
Investigational Medicinal Product Dossier (IMPD)
Investigator’s Brochure (IB)
Common Technical Document (CTD)
Review of documents prepared by the Sponsor
Safety Assessment/Expert Reports
Preparation of Scientific manuscripts

Our team helps to clarify regulatory expectations early, reduce delays and improve the quality of the documents to be submitted.

Development Planning and CRO Coordination

We work closely with our clients to define development programs and study designs that meet both scientific and regulatory requirements. From preclinical studies to first-in-human, we provide support in:

Overall program design
Individual study design
CRO identification and selection, to ensure they are suitable for each stage of development

Our aim is to streamline processes and align study plans with the long-term regulatory strategy.

Advantages for the customer

Accelerated regulatory timelines through early involvement of the authorities’
High-quality submissions that meet the expectations of EMA and FDA
Customised support for human medicinal products
Expert preparation for critical regulatory milestones
Integrated planning from study design to CRO coordination