Get it right the first time

Preparing a regulatory submission successfully requires significant effort and attention to detail. Errors and inaccuracies can lead to costly delays that you do not want to risk.

We accelerate the regulatory submissions of medical innovations worldwide through customized, tech-enabled regulatory solutions. Our seasoned experts leverage the latest technology and automation tools to speed up the process and minimize errors in support of your goals.

Here is what our partners say:

“Flexible, supportive and do their best to meet resourcing requests!” – Medical Communications Scientist at top 10 global pharmaceutical company

“I find their quality to be high and the staff to be professional. They meet timelines and comply with sponsor processes.” – Associate Director of Drug Safety at publicly traded, global pharmaceutical company

“Excellent customer service.  Diligent follow up.”  – Director at global, publicly traded pharmaceutical company based in Japan

How we help our clients

Regulatory Affairs and Submission Strategy

Navigate the complex process to accelerate your drug to market with customized development and regulatory submission strategy and guidance from seasoned experts.

Medical & Regulatory Communications

Reduce risk with writers who have deep expertise and experience to efficiently drive the document development process. We’ve achieved 125+ INDs in 5 years.

Regulatory eCTD Software

The GlobalSubmit™ platform allows you toefficiently publish, validate and review electronic common technical document (eCTD) submissions. Eliminate risk and avoid unnecessary steps.

Regulatory Operations

Streamline your electronic submissions and file on time with dedicated and scalable publishing teams who provide visibility throughout the entire process.

Regulatory Technology

Advance your approvals with accuracy and speed using industry-leading artificial intelligence for writing and content reuse, submissions management, and transparency and disclosure.

Safety and Pharmacovigilance

We support safety-related document authoring throughout the lifecycle for all major global agencies. This includes safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans and more.

Transparency and Disclosure

We provide expertise, services, and technology to enhance engagement of study participants and the public. We address your specific initiatives and risk tolerance while maintaining compliance.
Achieve regulatory milestones

We focus on strategy first, and then map an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management.

We ask the right questions during front end meetings and working together, assess the right processes, tools, and resources to achieve all your goals.

Supporting you from R&D through life cycle management

An astonishing number of documents, communications, and presentations must be produced at every stage of development.

Our highly skilled and scalable team manages the transition from pre-clinical programs to clinical development, through submission and approval, to post marketing safety with rigorous and proven quality control processes.

How can we help you?

Contact us today to discuss how we can help you achieve your regulatory milestones.