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Regulatory Process Products

Accelerating Innovation, Delivering for Patients

We provide end-to-end regulatory affairs services throughout the entire lifecycle of your medicinal product – from early development clinical trials, through to major agency submissions (NDA, MAA, BLA) and post-approval maintenance.

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Our experience covers all types of medicinal products, markets (EU, US, UK and rest of world) and therapeutic areas, involving small molecules, biologicals, biosimilars, branded and generic products. We accelerate innovation through our highly-respected regulatory affairs team, who have decades of experience in delivering regulatory solutions and strategic guidance to a wide portfolio of clients, tackling some of the most technically challenging projects, delivering successful client outcomes that are flexible and cost-effective and that offer exceptional value to clients from both commercial and scientific standpoints.

 

Furthermore, we deliver for patients and keep them at the center of what we do. Whilst performing all of our services, we are conscience of the impact to patients, and this drives us to be the best at what we do.

Our Services

Regulatory Process Products

  • CTD Templates

  • Regulatory strategy template, submission strategy workflow, change control workflow, Prince2 style timeline calculator, prince 2 project plan, prince 2 submission (stage) plan, submission workflow EU, US clinical, MAA and post approval. Submission formatting guide

  • Regulatory Wiki - subscription

  • Bespoke Regulatory Process Development - e.g. change control process, SOPs, best practice guides

  • Critical Review of Regulatory Process and Systems

  • Bespoke eLearning creation service - we create training for your teams e.g. training on internal processes, systems, procedures, etc.

  • Project Management - we can manage any project

  • Bespoke Consulting Service - we can provide solutions for any regulatory or project related issues you experienced.

  • Problem Resolution Service - We can create a tailored solution for any problems that you encounter within the regulatory affairs function

Marketing Authorisations

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Lifecycle Management

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Other CMC Activities

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Entry to regulatory have a strong technical background, they have an immense knowledge of regulatory, organizational skills and ability to execute efficiently... their expertise has been valuable in proactively identifying and addressing any potential gaps that can lead to future questions from agencies

Mrs R. M

The entry to regulatory team are well organized, have excellent communicational skills, both oral and written...they are knowledgeable, self-motivated, work with a sense of urgency, and are great team players.

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Mr B. H

Entry to regulatory consistently show strong leadership capabilities when it comes to directing, supporting, and involving peers... Proving to be knowledgeable in their area of expertise.

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Mr P. T

Entry to regulatory always attend meetings prepared and do not miss an opportunity to progress a task, initiative, or deliver the next stage in the process.

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Mr P. T

Entry to regulatory are talented regulatory professionals, they understand and interpret the regulations well and are excellent technical writers.

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Mrs S. B

I have worked with Entry to regulatory on manufacturing site registration/transfer project for a multimillion pound EU/ROW product. They were involved in creating and coordinating the response strategy, writing and compiling module 3 and technical documents along with answering challenging agency questions.

Mr S. K

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I had the pleasure of working with Entry to regulatory on an extremely busy & challenging product... Entry to regulatory are highly capable and knowledgeable Regulatory Professionals and would be a benefit to any team.

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Mrs T. B

I had the pleasure of working with Entry to Regulatory, as part of a collaborative effort to intensively support a critical CMC submission with a range of complex changes... The overall strategy resulted in up to 14 hours intensive preparation per day for one week.

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Dr L. O

Client Case Studies

Expert Experience

Positive Feedback

Our DNA Infographic

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