SERVICES
Our Services
We offer the following services:
Regulatory CMC Support
Whether seeking a new marketing authorization, expanding into new markets, or making changes across multiple markets, we provide the CMC support to make your project happen.
Our expertise is in dossier writing, including modules 3.2.S, 3.2.P and DMFs.
We have experience in the following markets: EU, US, Canada, China, APAC, LATAM and MEA.
For both drug substance and drug product
From Consumer Healthcare Products through to Prescription Medicines
Topical to implantable
Small molecule through to biologic
Aseptic and non-aseptic manufacture
We cover the full spectrum of regulatory procedures, including:
Marketing authorizations
Variations
Notifications
Renewals
Annual reports
Responses to questions
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Regulatory CMC Compliance Audits
Continuous monitoring is needed to minimise the risk of regulatory non-compliance.
Regulatory non-compliance can result in product release into markets being stopped or product recall, suspension or revocation of marketing authorization as well as other sanctions including fines and even terms of imprisonment.
To support companies in maintaining regulatory compliance for their marketed products we offer:
Independent audits of current site practices against the registered information (CMC dossier)
Single market checks for a range of products
Multiple market checks for a single product
Gap identification and classification
Gap closure strategy
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Medicinal Cannabis and Related Products
Regulatory support for marketing authorisation applications (registration), clinical trial applications, irradiation licenses, and product maintenance (variations)
Dossier writing (CTD Module 3, IMPD-Q)
Products covered: Cannabis flower, CBD, Dronabinol/THC
Markets covered: EU (especially Poland, Denmark, Germany), Australia, New Zealand
Advising on:
CMC/quality-related aspects
Regulatory compliance
Regulatory strategy
Borderline products
GMP and GACP aspects
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Translation and Editing
Proof-reading and editorial correction of technical documents, manuscripts and presentations in English.
Preparation of declarations and statements in English.
Translation of technical documents from German into English (e.g. SOPs, reports).
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Regulatory CMC Outsourcing
Outsourcing of CMC-related activities for well-established products allows limited internal resources to be more effectively used.
As an alternative to large CMC outsourcing companies, we offer a small, bespoke service tailored to fit your individual needs. We recognize that one size does not fit all.
We work with your existing systems, processes and product experts in way that ensures less (not more!) work for you.
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