Any Time, Everywhere
We are a leading product development and regulatory affairs consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market, minimising development costs and ensuring continued supply. We keep our client's needs and the patients who benefit at the heart of what we do.
A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.
Our team offers strategic and operational support in the fields of CMC and regulatory, which guide products efficiently from early development to marketing approval and post-approval maintenance.
Our Experts have worked with the following organisations:
European Medicines Agency (EMA)
Medicines and Healthcare products Regulatory Agency (MHRA)
Merck & Co (Merck, Sharp & Dohme, MSD)
Our Feedback is Exceptional
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
Testimonials and Awards