Our deeply-experienced Regulatory experts can provide help right across the regulatory lifecycle, to ensure that dossiers are up to scratch pre-, during, and post-submission.
From initial dossier review and gap analysis, to hands-on help with eCTD submissions, to longer-term variation management, we’ll help you accelerate market delivery and maintain ongoing compliance.
We can provide these services for both drug substances and for finished drug products.
We’ll review your dossier and provide a detailed gap analysis so that you can ensure your submissions are successful first time.
Our experts can help you fill any gaps, draft content as needed, and submit the finished dossier to the relevant agencies in the correct eCTD format.
We’ll help you maintain compliance on an ongoing basis, ensuring robust variations management and continuous tracking of evolving authority requirements.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
About this Case Study The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as …
Rephine to Exhibit at the Upcoming India TrackWise User Group in Mumbai on September 1st We’re thrilled to announce that the Rephine India team will …
With Rephine everyone’s a winner! Thank you for visiting us! Submit the form and take advantage of some sweet offers: 15% off library report*Or10% off …
Rephine’s Chinese division signs to provide Implementation and Validation services for TrackWise EQMS solutions. Stevenage, Hertfordshire, 4 August, 2023 – Rephine, the experts in …
About this Case Study The case study involved a pharmaceutical company seeking to bring a product, manufactured in Europe, into the US market for commercialisation. …
About this Case Study The case study involved verifying GMP compliance in an IVD company to enable the commercialisation of their products in the USA. …
Rephine now offering QMS services to medical device companies through new partnership. Stevenage, Hertfordshire, 28 July, 2023 – Rephine, the experts in quality assurance & …
About this Case Study The case study involved updating the Technical File documentation for more than100 IVD products according to Regulation (EU) 2017/746. The company …
About these recordings Missed out on the insightful sessions and captivating discussions from our esteemed speakers at the Rephine Symposium? Don’t worry, we’ve got you …
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