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Regulatory Affairs Consulting

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.

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

Early Development Clinical Trials

  • Agency meetings, Scientific Advice / Protocol Assistance

  • Advisory Committee meetings & preparation

  • Clinical Trial Filing (CTA and IND)

  • Regulatory Strategy

  • Investigator Brochure / IMPD / IND authoring

  • Risk management planning

  • Early Access Programs, PRIME, Breakthrough Therapy Designation

  • Paediatric Investigation Plans (PIPs), Orphan Designations

  • Expert Advice (Quality)

  • Global Regulatory Intelligence

Marketing Authorisations

  • Authoring of MAA, NDA, BLA, ANDA submissions

  • Regulatory Strategy

  • Risk management

  • Full procedure support for US and EU application procedures (National, MRP, DCP, CP)

  • Module 1 preparation

  • Module 2 Quality Overall Summary

  • Module 3 Quality

  • Artwork and Labelling (including Summary of Product Characteristics (SmPC), Company Core Data Sheets (CCDS), Product Information Leaflets (PIL) etc.)

  • Support for pre-submission meetings

  • Local regulatory intelligence and support

  • Response to Agency questions

Lifecycle Management

  • Variations

  • Amendments/supplements

  • Regulatory strategy

  • Risk management

  • Product licence renewals

  • Annual reports

  • Line extensions

  • Artwork and labelling

  • Technical authoring

  • Submission management

  • Expansion into new markets

  • Regulatory intelligence

  • Local submission support

Other Activities

  • Project Management

  • Medical Writing (e.g. IMPD, NDAs)

  • Change control assessment

  • Advice and consultancy

  • CMC Gap Analysis

  • Data collection and collation

  • Adjudication

  • Remediation

  • Health Authority communication

  • Manufacturing site rationalization

  • Site transfers

  • Change of ownership

  • Due-diligence and divestment

  • CMC compliance

  • CTD build and conversion projects

  • Process Improvements

  • Training 

  • Program SWOT analysis

If you require support in an area not mentioned above, then don't hesitate to contact us and we can work with you to provide a solution

At Entry to Regulatory,

We tailor our services to fit your budget and requirements

Speak to our experts now

We are excited to offer an unbeatable deal to new customers!

Get the first 7 hours of regulatory consulting absolutely free when you sign up.

Our experienced team of consultants can help you navigate through the complex regulatory landscape, saving you time and resources.

Take advantage of this limited time offer and get started today.

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

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

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.

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.

Dr L. O

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.

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.

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.

Mr P. T

Note: Full names have not been included to protect client confidentiality

Our Experts have worked with the following organisations:

  • European Medicines Agency (EMA)

  • Medicines and Healthcare products Regulatory Agency (MHRA)

  • GlaxoSmithKline (GSK)

  • Pfizer

  • Gilead

  • Biogen

  • Merck & Co (Merck, Sharp & Dohme, MSD)

  • Bayer

  • And more...

Global Regulatory Solutions

We provide regulatory services to the following markets:

  • Europe (EU)

  • United States (US)

  • United Kingdom (UK)

  • Europe dependent markets (e.g. Switzerland, Ukraine, CIS markets)

  • Middle East (e.g. UAE, Qatar, Oman, Saudi Arabia, Iran, Kuwait)

  • Asia (e.g. Hong Kong, South Korea, Singapore)

  • Africa (e.g. South Africa)

  • Turkey

  • Canada

  • Australia

  • Russia

  • China

  • Japan 

  • Brazil 

  • Mexico

If you require services for a market not included in the list, then contact us to enquire.

Client Case Studies

Our DNA Infographic

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