service category: Regulatory Affairs

Design or assist with the design of regulatory strategy

Planning for Regulatory Success: Designing Regulatory Strategies Our services encompass designing or assisting with the design of regulatory strategies, providing clients with a roadmap for achieving regulatory success. Our expert team collaborates closely with clients to understand their unique goals, product requirements, and regulatory environment, tailoring strategies to their specific needs. We conduct thorough assessments […]

Author and/or review IND, IMPD, NDA, BLA, DMF, and CTA applications, amendments and supplements

Expert Application Assistance: Authoring and Reviewing Regulatory Submissions Our services encompass the authoring and review of IND, IMPD, NDA, BLA, DMF, and CTA applications, amendments, and supplements, ensuring accuracy, completeness, and compliance with regulatory requirements. Our experienced team possesses in-depth knowledge of regulatory guidelines and requirements, enabling us to provide comprehensive support for the preparation […]

Technical and Medical Writing

Expert Communication: Technical and Medical Writing Services Our technical and medical writing services provide clear, concise, and scientifically accurate documentation to support regulatory submissions, research publications, and product communication. Our experienced team of writers combines scientific expertise with exceptional writing skills, ensuring the effective communication of complex concepts to diverse audiences. We specialize in developing […]

Advise on regulatory options and potential pathways

Guiding Regulatory Success: Advice on Regulatory Options and Pathways Our services provide invaluable advice on regulatory options and potential pathways, enabling clients to navigate the regulatory landscape with confidence and clarity. Our expert team leverages in-depth knowledge and experience to assess the regulatory environment, helping clients understand the available options and identify the most appropriate […]

Assist with preparations for FDA interactions

Streamlined FDA Interactions: Assistance with Preparations Our services include expert assistance with preparations for FDA interactions, facilitating smooth and productive engagements with regulatory authorities. Our experienced team provides guidance and support in preparing for meetings, such as Pre-Investigational New Drug (Pre-IND) meetings, Pre-Submission meetings, and Pre-New Drug Application (Pre-NDA) meetings, ensuring clients are well-equipped to […]

Represent clients in interactions with FDA and EMA

Expert Representation: Interacting with FDA and EMA Our services encompass expert representation, advocating for clients in interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), ensuring effective communication and alignment with regulatory authorities. Our experienced team serves as a knowledgeable liaison between clients and regulatory agencies, providing expert guidance […]

Conduct due diligence

Empowering product development in small molecules, biologics, and combination products. Our comprehensive support guides clients towards success in the ever-evolving landscape of pharmaceutical innovation.