Named products stated on the company site: OEL Fastrac (downloadable OEL/ADE monographs)OEL Fastrac+ (subscription digital solution)Affytrac (EHS software)and a Virtual Risk Assessment service.
No certifications or regulatory registrations are claimed by the company on its site. It states that its ADE/PDE monograph work addresses EMA requirements for ADE/PDE values. Individual staff credentials stated: DABT and ERT toxicologists.
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Courage in the Path Forward. Bold & Innovative Solutions for Biopharma & Pharma Ventures.
None stated. The site claims no certificationsstandardsor inspectorate registrations.
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Available nowDevelopingView Regulatory, Scientific & Safety Consulting in Life Sciences
Certifications explicitly claimed by the company: ISO 9001:2015ISO 13485:2016 and ISO/IEC 27001:2022. No GMPPIC/S or inspectorate registrations are claimed.
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Pharmaceutical Regulatory Affairs
Certifications explicitly claimed by the company: ISO 9001:2015 under Italcert certificate N.544SGQ06covering "planning and provisions of consultancy services in regulatory affairspharmacovigilance and scientific information"; and ISO 13485:2016 (UNI CEI EN ISO 13485-2021) under Italcert certificate N.544DM05covering "services in the regulatory
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Available nowDevelopingView Regulatory clarity, from thought to finish.
No certifications or registrations are claimed by the company. It states its team has "decades of experience in senior positions at the FDAEMA and throughout industry" and cites "300+ years of collective FDA experience." It states it performs regulatory compliance assessmentsgap analyses and mock inspections aligned with FDAEMA and international expectations
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Available nowDevelopingView Brilliant science deserves operations to match.
MES selection and implementation with "vendor-specific depth including major platforms such as PAS-X" (company wording); automation and shopfloor/IT-OT systems integration; serialisation; GxP digitisation and CSV.
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Available nowDevelopingView Your Partner for Global Regulatory, GMP Services & Third-party audits.
States "ISO 9001 : 2015 Certified for Quality Management Systems". Describes consulting expertise and client work covering EU GMPPIC/S and TGA GMPUS FDA pathways (505(j)505(b)(1)
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Clinical.net — the company's in-house developed EDC / digital clinical platformwhich the company states 'has been validated in accordance with FDA 21CFR part 11 requirements'.
The company's quality assurance page statesverbatim: 'Our systems are ISO 9001 and 27001 compliant.' Its homepage lists 'ISO 9001:2015ISO 27001:2014 and FDA 21 CFR Part 11 compliant'. It states it 'adheres to ICH/GCPinternational and local laws and requirements'
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States it is a Manufacturing and Importation Authorisation (MIA) holderauthorisation number M20117/00001authorised by the HPRA (Ireland)and that it is listed on EudraGMDP as Manufacturer (Importer). States QP certification work under EU GMP Annex 16 and importation controls aligned with EU GMP Annex 21
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Available nowDevelopingView We support you locally, thinking globally.
Company states it is ISO 9001 certified (footer: "ISO 9001 Certified compliance services provider since 1998") and ISO/IEC 27001:2022 certified. It also states recognitions: Deloitte Private Best Managed Company 2021-2024Great Place to Work Certified 2022-2024Women Owned Certifiedand an EcoVadis commitment badge for excellence in sustainability. As a consultancy it does not claim manufacturing authorisations of its own.
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Company lists "Software Solutions & Services" as one of its service lines alongside consulting; no specific platform product is named on the pages read.
The company's own site lists ISO 13485:2016 certificationISO/IEC 27001:2022 certificationa GMDP licenceand EUROTOX. No ISO 9001 claim was found on the pages read.
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Global Audit Library — a subscription library of third-party GMP audit reportsdescribed by the company as covering more than 2500 individual products with three-year report validity. Computer systems validation and data-integrity servicesincluding TrackWise implementation support.
Rephine states on its About page: "We achieved ISO 9001:2015 Certificationthe world's most recognised quality management standardfor our UK (Stevenage) and Spain (Barcelona) teams." It also states: "Rephine Barcelona S.L. is now accredited to ISO/IEC 17020 as an inspection body for specific GMP and GDP audit activities." Audit and consultancy work is described against EU GMP (including Annex 11 and Annex 15)ICH Q7/Q9
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Para IV Insights (pharmaceutical database)GenUS (drug classification and competitive-intelligence database)Pharmalysis (strategic industry reports). Delivered as a subscription web platform with login/registration.
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Stated products: Controlled Substances Squared (CS2) — chemical-structure-based screening of chemical collections against controlled-substance listsincluding analoguesderivatives and estersupdated weekly
No certifications (no ISO 27001ISO 9001 or similar) are stated on the company's website or LinkedIn page. The regulatory lists the company states CS2 encodes include: national controlled-drug legislation from 28+ countriesthe Chemical Weapons Convention (including the Australia Group)EU controlled-drug precursor / military dual-use / human rights lists
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Available nowDevelopingView Maximising your value through the integrated application of Pharmaceutical Development and Clinical Pharmacology expertise
Formulation screening and development laboratories; preclinical-to-clinical translation and pharmacokinetic modelling; dissolution test development and justification including clinically relevant dissolution specifications (CRDS).
Seda states that specialist CMC regulatory consultants are available "including an ex-MHRA Assessor"and that it supports regulatory agency interactionsbriefing materials and face-to-face representationphase-appropriate regulatory strategy
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Available nowDevelopingView Un unico partner per l'intero ciclo di vita dell'impianto nel settore Life Sciences (a single partner for the entire plant lifecycle in the Life Sciences sector)
In-house capabilities listed by the company: process simulationComputational Fluid Dynamics (CFD)BIM with laser scanning and a Common Data Environment (CDE)3D printing
The group offers GMP consultingcontamination and biocontamination consultingcommissioning and qualificationand FDA/AIFA consulting as services. Published credentials are B Corp certification
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We promote pharmaceutical traceability at a global level.
Verifarma Track & Trace (serialisation and aggregation)eQMS (electronic quality management system)Vera (AI assistant for the quality solutions)and SAP Business One ERP implementation as an official implementer. The company states implementation within 60 days.
Verifarma publishes the following claims on its own site: "ISO 9001 — Quality Management""ISO 27001 — Information Security""Validated in accordance with GAMP 5""GS1 — Meeting standards since 2008"
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No certificationsstandards or inspection history are stated anywhere on the company website. The company names only the authorities it works with: ANVISA (Brazil)Infarmed (Portugal)EMA and EDQM (EU).
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