Our Solutions

Insight/ɪnsʌɪt

'An accurate and deep understanding'

We understand that your journey from discovery to approval can be challenging. This is why we believe that even at proof of concept stage, expert advice can mitigate project risks. Whether you prefer "pay as you go" ad hoc advice, or a full fixed fee project management service, we can help. Wherever you are in your journey, reach out to us and let's explore how we can optimise your chances of regulatory success together.

OUR SOLUTIONS

Regulatory

With so many options, steps and procedural complexities throughout development and during registration, choosing your regulatory strategy can be a daunting task.
We can clarify the options, advise on the best solution, and design and implement the best roadmap for your product.

We support you with

  • Regulatory strategy
  • Orphan Drug Designation
  • PRIME
  • PIP
  • Scientific Advice procedures
  • Preparing for MAA submission
  • Choice of MAA legal basis and procedure
  • Life cycle maintenance
  • Variations
CMC

CMC aspects are critical at all stages of product development, from first in humans stage of development to activities such as cost optimisation post marketing.
We can advise and support at all stages of development to ensure a smooth path to approval at each step in your product's journey.

We support you with

  • Gap analysis
  • Dossier Authoring
  • Technical advice and troubleshooting
  • Quality by Design and Real Time Release Testing
  • Rapid Microbial Methods
  • ATC code applications
  • Scientific advice briefing, book authoring and review
  • Development roadmaps
Clinical and Non Clinical

We have a team of highly experienced ex-Regulators, ideally placed to advise on Clinical and Non-Clinical strategies at all phases of development.

We support you with

Clinical

  • Indication Definition
  • Clinical Development Roadmaps
  • Scientific Advice
  • Gap Analysis
  • Clinical Trial Design
  • Clinical Study Protocol Authoring

Non-Clinical

  • Early Phase Development Roadmaps
  • Toxicology and PK Study Design
  • Scientific Advice
  • Gap Analysis

Swiss Affiliate Services

Swissmedic require local representatives in Switzerland for the purposes of all regulatory activities.
We provide a full service for Pharmaceutical Companies who wish to conduct Clinical Trials or perform Lifecycle Maintenance activities.

We support you with

  • SwissEthics Submissions
  • Clinical Trial Submissions
  • Clinical Trial Applications
  • Variation Submissions
  • Marketing Authorisation Applications
Publishing & Submission

Our expert publishing team create high quality and technically validated electronic submission packages for submission to EU (EMA, MHRA, National Agencies), the USA (FDA) and Swissmedic.
For Swissmedic CTAs we also support submissions by hard copy or CD through our local office.

We support you with

  • eCTD eSubmission Management
  • Swissmedic BASEC and CD Submissions
  • Clinical Trial Information Service (CTIS)
EU Initiatives

Access to SME and ODD incentives are limited to companies with a legal establishment in the EU.
With InsideReg offices in Ireland, we are ideally placed to access these incentives on behalf of our clients

We support you with

  • SME status applications
  • Orphan Drug Designation Holding
  • EMA IRIS and SPOR registration support

Client Feedback



Clinical stage biopharmaceutical company / CTO

Laura’s support and guidance was instrumental on bringing our first compound in to the clinic. The high quality initial work has further set us up well to obtain smooth approvals for our subsequent submissions.

Large Biotech / Regulatory Director

Very responsive and helpful

Get In Touch!

Switzerland
Head Office
InsideReg Sàrl
rue du Château 4
1350 Orbe
Switzerland


United Kingdom
Summit House
10 Waterside Court
Albany Street

Newport
NP20 5NT

Ireland - EU
22 Northumberland Road
Ballsbridge
Dublin 4
Ireland
D04 ED73

www.insidereg.com 

contact@insidereg.com

+41 21 802 17 88

Switzerland
Head Office
InsideReg Sàrl
rue du Château 4
1350 Orbe
Switzerland

United Kingdom
Summit House
10 Waterside Court
Albany Street

Newport
NP20 5NT

Ireland - EU
22 Northumberland Road
Ballsbridge
Dublin 4
Ireland
D04 ED73

www.insidereg.com contact@insidereg.com
+41 21 802 17 88