Useful Links of various regulatiry authoirity website

Country	Authority	Website
Australia	Therapeutic Goods Adminstration (TGA)	www.tga.gov.au
Austria	Bundesministerium für Geshundheit und Frauen and Environment	www.bmgfj.gv.at
Belgium	Federal Public Service Health, Food Chain Safety	www.health.belgium.be/eportal
Bulgaria	Bulgarian Drug Agency	www.bda.bg
Canada	Health Canada	www.hc-sc.gc.ca/index-eng
Cyprus	The Ministry of Agriculture, Natural Resources and Environment	www.moa.gov.cy
Czech Republic	State Institute for Drug Control	www.sukl.cz
Denmark	Danish Health & Medicines Authority	www.laegemiddelstyrelsen.dk/en
Estonia	State Agency of Medicines	www.ravimiamet.ee
Europe	European Medicines Agency (EMA)	www.ema.europa.eu
Europe	Heads of Medicines Agencies (HMA)	www.hma.eu
Finland	National Supervisory Authority for Welfare and Health	www.valvira.fi/en
France	Agence nationale de Sécurité du medicamente et des produits de Santé (ANSM)	www.ansm.sante.fr
Germany	Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)	www.bfarm.de
Greece	National Organization for Medicines	www.eof.gr
Hungary	National Institute of Pharmacy	www.ogyi.hu
Iceland	Icelandic Medicines Agency	www.lyfjastofnun.is
Germany	Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)	www.bfarm.de
India	Central Drugs Standard Control Organization	cdscoonline.gov.in/
Ireland	Irish Medicines Board (IMB)	www.hpra.ie
Italy	Agenzia Italiana del Farmaco (AIFA)	www.agenziafarmaco.it
Japan	Ministry of Health, Labour and Welfare	www.mhlw.go.jp
Latvia	State Agency of Medicines of Latvia	www.zva.gov.lv
Liechtenstein	Landesverwaltung Liechtenstein	www.llv.li
Lithuania	State Medicines Control Agency (SMCA)	www.vvkt.lt
Luxembourg	Ministère de la Santé	www.etat.lu/MS
Malta	Medicines Regulatory Unit	www.ehealth.gov.mt
Netherlands	Medicines Evaluation Board (MEB)	www.cbg-meb.nl
New Zealand	Medsafe	www.medsafe.govt.nz/
Norway	Norwegian Medicines Agency	www.legemiddelverket.no
Poland	The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	www.urpl.gov.pl/en
Portugal	Instituto Nacional de Pharmacia e do Medicamento (INFARMED)	www.infarmed.pt
Romania	Romanian Medicines Agency (ANMDM)	www.anm.ro
Slovak Republic	State Institute for Drug Control	www.sukl.sk
Slovenia	Ministrstvo za zdravje Republike Slovenije	www.mju.gov.si
South Africa	Medicines Control Council (MCC)	www.sahpra.org.za/
Spain	Agencia Española de Medicamentos y productos Sanitarios	www.aemps.gob.es
Sweden	Medicinal Products Agency (MPA)	www.lakemedelsverket.se
Switzerland	Swissmedic,Schweizerisches Heilmittelinstitut	www.swissmedic.ch/
United Kingdom	Medicines and Healthcare Products Regulatory Agency (MHRA)	www.mhra.gov.uk

Who we are and What we do

We, are a group of young, enthusiastic and experienced pharma regulatory affairs professionals having expertise and rich exposure to the pharmaceutical industries. We are involved in providing Regulatory Consulting Services covering services for prescription (branded/generic, OTC, Nutraceutical products. Etc…)

We support our clients in preparation and reviewing of various documents as per ICH, GCC, ASEAN, CIS, LATAM, Africa and ROW regulatory authorities’ requirements like,

• Technical Documents like Standard Test Method, Standard Test Specification, Batch Manufacturing Report (BMR), Product Development Report (PDR), Stability Data, Process Validation Report, and Comparative Dissolution Profile Report (CDP) etc.
• Preparation and Compilation of Dossier and DMFs.
• Analytical Validation and Verification Report for Raw material, Formulation, Related substances etc.
• Risk Management Plan (RMP), Leaflet, SmPC.
• Expert Report Writing, QoS.
• Regulatory CMC strategy and complete support to CMC queries.

If you are in search of any of the above requirements, kindly get in touch with us. We believe in utmost care, completeness and quality assured work following timelines.

 

Kindly let us know about your requirements in the below comment section and we will get in touch with you in a while.