Reg-World
We have a strong network named “Reg-World” across the globe. We help our clients to register products in the EU, USA, Canada, Australia and New Zealand, ASEAN, GCC and EURASIA region.
CMC Authoring
We perform CMC authoring of Cell and Gene Therapy (CGT) products, biological products, small molecules and Active Pharmaceutical Ingredients (API).
Reg-Pub
Our expert operations team is well equipped with exclusive and advanced eCTD tools and plug-ins. We are capable of tracking, executing and managing the regulatory operations of all submission types for our clients.
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Reg-Resources
We overcome the resource gap in the industry by providing qualified and efficient resources for both long- and short-term positioning. Our experience helps to identify the skill set needed for specific roles.
We offer Regulatory Solutions for:
Cell and Gene Therapy Products
We provide CMC authoring support that helps our clients to submit the content “right” first time.
Biological Products
We provide authoring and submission support for biologicals eg, monoclonal antibodies, recombinant DNA products and vaccines to accelerate approval of clinical trial applications and marketing authorization applications.
Small Molecules
We keep ourselves abreast with the current and evolving scientific guidelines, which helps us to provide excellent support in designing regulatory submission strategy, authoring, compilation and submission of applications for small molecules during pre-and post-authorization stages.
APIs
We provide support in the submission and management of Certificate of Suitability (CoS) dossiers to EDQM, Active Substance Master Files (ASMF) to EU/UK, Drug Master Files (DMF) to the US, Canada, Korea, and Most of the World (MoW) markets.
Reg-Intelligence
We help our clients to develop regulatory and CMC intelligence databases. The content development is based on country-specific regulations/guidance documents, input from our local network (Reg-World) and our past experience.
Reference Standards
We procure reference standards from various pharmacopeial bodies and supply them to our clients for analysis purposes. We also help clients to purchase columns and/or other analytical materials.
GMP Compliance
Our team has extensive knowledge of GMP regulations and their interpretations, which help clients to meet various compliance requirements.
Medical Devices
We provide support in device classification, compilation of technical files and registration of medical devices.
QMS Support (ISO 13485)
We enable our clients to set up Quality Management System (QMS) from start, perform gap analysis and provide internal audit support and QMS training to the staff.
What our clients say
Our clients are the best testament to our acumen and capability.
“We have had the pleasure of working with our partners at RegWeb for several years across many clients and regions. The team are extremely detail orientated and organised when preparing their excellent written documents for regulatory submissions. Additionally, the team are very personable and integrate into projects seamlessly, they are our trusted partners in North America and we continue to build a Rapport year on year!”
Ifty Saiyed
“We from Clarivate Cortellis CMC intelligence team glad to provide this testimony to the work done by RegWeb team on providing the professional services to develop and further maintain the CMC Intelligence database. RegWeb consulting team have always done their best to meet the exact requirements of the CMC project and helped us to achieve the internal milestones to publish the content for Biologics development for identified Regulatory entities across the globe. And now we are pleased to extend their services for Small molecules maintenance as well.”
