Types of Products we work with..

Main Categories

✿ Medical Devices (MD)
✿ In Vitro Diagnostics (IVD)
✿ Medicinal Products
✿ Companion Diagnostics
✿ Food & Food Supplements
✿ Veterinary Products

Biological Categories

✿ Recombination Products
✿ Monoclonal Antibodies
✿ Vaccines
✿ Blood and Blood components
✿ Cell/Tissue Therapy Products
✿ Xenotransplantation

Other Categories

✿ Combination Products
✿ Borderline Products
✿ Pediatric Drugs
✿ Orphan Drugs
✿ OTC Drugs
✿ Generic Drugs
✿Shortage Drugs
✿ Homeopathic Preparations
✿ Cosmetics
✿ Chemicals and Biocides

Competent Authorities and Medical Agencies that we work with..

✿ It is a comprehensive list of the Governmental bodies, Competent Authorities and Medical Agencies that we work with and help you with registering your products across the Globe.
✿ Needless to mention, if any other countries not listed here, if you are interested and planning to register your products, kindly contact us and we assure to work with them.

✿ European Union (EU) Countries (27)
✿ European Economica Area (EEA) Countries (30)
✿ It includes EU Countries + Iceland, Liechtenstein, Norway
✿ European Free Trade Association (EFTA) Countries (4)
✿ It includes 4 member states Iceland, Liechtenstein, Norway and Switzerland

Asian Countries


Middle East

North America

South America

Notified Bodies we worked with..

✿ NB: LNE/GMED; Products: IVDD General Devices/IVDR Class A and B
✿ NB: RISE; Product: MDD Class II
NB: Intertek/IMNB; Products: MDD Class I, Im, Iib /MDR Class A and B
✿ NB: Dekra; Products: MDD Class Iib
✿ NB: BSI; Products: MDD Class IIa and IIb
✿ NB: DNV Nemko Safe; Products: MDD Class IIb
✿ NB: UL; Products: IVDD Class I and II

Standaridization Organisations

✿ International Organization for Standardaridization (ISO)
✿ International Electrotechnical Commission (IEC)
✿ The European Commission for Standaridization (CEN)
✿ The European Committee for Electrotechnical Standaridization (CENELAC)
✿ International, European Normalized (EN) and National Standards (Ex: Swedish Standard-SS)
✿ In house standards

Regulations & Standards that we work with..


Medical Device Directive 93/42/EEC To Medical Device Regulations 2017/745


In Vitro Diagnostic Directive 98/79/EC To In Vitro Diagnostic Regulations 2017/746

ISO 13485:2016

Medical Devices - Quality Management System – Requirement for Regulatory purposes

21 CFR 820 QSR

Quality System Regulation


Medical Device Single Audit Program

EN ISO 14971:2012 & 2019

Application of Risk Management to Medical Devices

IEC 60601-1{ed3.1}

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

MEDDEV 2.7/1 Ver 4.0

Clinical Evaluation: Guidelines on Medical Devices

IEC 62366:2015

Application of usability engineering to medical devices

SS:EN 62304:2006

Medical Device Software - Software life-cycle processes

ISO 10993:2018

Biological evaluation of medical devices

ISO 11608:2014

Needle based injection systems for medical use

Platforms we work with..

General IT Skillsets

✿ Microsoft Windows
✿ Unix / Linux
✿ Microsoft Office Package / Share Point
✿ PERL Programming / Adobe Illustrator for Artwork
✿ Adobe Professional, Nuance for PDF, Nitro Pro PDF,
✿ In house developed databases

Specific Software Applications

✿ EDC system (RAVE, Ethical e-Adjudication)
✿ Creation of e-CRF using PheedIT.
✿ Data Management using SAS Programming
✿ MEDRA & ICD-10 medical coding.
✿ Project management tools such as ANTURA, Project Place & Asana
✿ Project Timeline Tool Gnatt