OUR SERVICES

The environment in which Pharmaceutical and Life Sciences companies operate is increasingly challenging, being driven by a more and more demanding healthcare agenda. The global need for innovative, cost effective medicines continues to rise whilst regulators , payers, health care providers and patients are demanding greater value for money, proven effectiveness of products, more transparency and access to information. To meet these demands companies are seeking ways to improve R&D productivity, increase the efficiency of its operations, rationalise spending on sales and marketing and enhance financial performance. 

 

Manufacturing

 

We offer  products under private label for exports from our third party manufacturing units for following categories:

Products manufactured under Beta Lactums and Non Beta Lactum sections under therapeutic categories of categories of Anti-Biotics and Anti- Bacterials, Cephalosporin Formulations, Anti Fungals, Oncology Drugs (Anti-Cancer), ARVs, Cardio-vascular drugs, Anti-Diabetics, Anti-Ulcerants, Anti-Histamines, Anti- Asthmatics, Anti-Cold and Cough, Anti Pyretics, Haematinics, Multivitamins, Enzymes, Immune Builders, Proteins, Calciums, Anti- Osteoarthritis, Appetisers, Anti-Oxidants, Ant Helmenthics, Anti-Emetics and Nauseants, Anti Inflammatory, Musculo-skeletal drugs, drugs for Erectile Dysfunction, Fertility, Obesity, Gynaecological disorders, Anti-Malarials, Psychiatry Drugs, Sedatives and Tranquilisers, Anti-Neuro Degenerative including various therapeutic segments.

Documentation Provided / Advantages:

Products manufactured by DMF grade APIs F&D, Stability studies & validations done in house Provide registration dossiers as per CTD / ACTD with Bioequivalence and DMF COPP / CFS / WHO-GMP Certificate and PIC/S compliant.

Research and Development

 

Since its inception, Amigoz lifesciences  has relentlessly pursued the most innovative and expert talent across a wide variety of products, dosage forms and delivery mechanisms resulting in a Research & Development team the company believes is without equal in the industry.

The Amigoz “Quality-by-Design” approach brings a level of consistent excellence throughout the development process and solidifies the bedrock of excellence behind each of its products.

Amigoz scientists employ a unique formulation method and clinical study design allowing it to match bioequivalence across dosage forms and streamline the development process, resulting in an unrivaled 100% success rate in scale-up.

 

Regularity affairs Support

We offer a wide range of services in the areas of regulatory affairs and pharmaceutical product development for small to medium size pharmaceutical companies to help them to overcome the challenges within the rapidly evolving global pharmaceutical market.

AMIGOZ LIFESCIENCES strive to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust. We are committed to doing business in an ethical and socially responsible manner. 

Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We are have been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry.

USEFUL LINKS

European Agency Medicines (EMEA)
http://www.emea.europa.eu

Heads of Medicines Agencies (HMA)
http://www.hma.eu

DG Enterprises - Pharmaceuticals - Regulatory Framework and Market Authorisations
http://www.ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
http://www.ages.at

Belgium: Federal Public Service - Health, Food chain safety and Environment
http://www.afigp.fgov.be

Bulgaria: Bulgarian Drug Agency (BDA)
http://www.bda.bg

Cyprus: Ministry of Health
http://www.pio.gov.cy

Czech Republic: State Institute for Drug Control (SÙKL) 
http://www.sukl.cz

Denmark: Lægemiddelstyrelsen (DKMA)
http://www.dkma.dk

Estonia: State Agency of Medicines
http://www.sam.ee

Finland: National Agency for Medicines 
http://www.nam.fi

France: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)
http://www.afssaps.sante.fr

Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
http://www.bfarm.de/de/index.html

Greece: National Organization for Medicines
http://www.eof.gr

Hungary: National Institute of Pharmacy
http://www.ogyi.hu

Iceland: Icelandic Medicines Control Agency (IMCA)
http://www.imca.is

Ireland: Irish Medicines Board (IMB)
http://www.imb.ie

Italy: Agenzia Italiana del Farmaco (AIFA)
http://www.agenziafarmaco.it/aifa/servlet/section.ktml

Latvia: State Agency of Medicines
http://zaale.vza.gov.lv

Lithuania: State Medicines Control Agency
http://www.vvkt.lt

Luxembourg: Ministère de la Santé
http://www.etat.lu/MS

Malta: Medicines Authority
http://www.medicinesauthority.gov.mt

Netherlands: College ter Beoordeling van Geneesmiddelen
http://www.cbg-meb.nl

Norway: Statens Legemiddelverk
http://www.legemiddelverket.no

Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://www.urpl.gov.pl

Portugal: National Medicines and Health Products Authority (INFARMED)
http://www.infarmed.pt 

Romania: National Medicines Agency (NMA) 
http://www.anm.ro

Slovak Republic: State Institute for Drug Control (SIDC) 
http://www.sukl.sk

Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia 
http://www2.gov.si/mz/mz-splet.nsf

Spain: Agencia Española de Medicamentos y Productos anitarios
http://www.agemed.es

United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)
http://www.mhra.gov.uk

Australian Government Department of Health and Ageing (TGA) 
http://www.health.gov.au

Canada
Health Canada – Health Products and Food Branch
http://www.hc-sc.gc.ca

Japan
Ministry of Health, Labour and Welfare
http://www.mhlw.go.jp/english 

New Zealand
Ministry of Health http://www.moh.govt.nz

Switzerland
Swissmedic,Schweizerisches Heilmittelinstitut
http://www.swissmedic.ch

USA
Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) 
http://www.fda.gov/cder

Drug3k - Online Drug Encyclopedia 
http://www.drug3k.com

Association of the British Pharmaceutical Industry (ABPI)
http://www.abpi.org.uk

Association of the European Self-Medication Industry (AESGP)
http://www.aesgp.be

BioIndustry Association (BIA)
http://www.bioindustry.org

British Generic Manufacturers Association (BGMA)
http://www.britishgenerics.co.uk

Drug Information Association (DIA)
http://www.diahome.org

European Directorate for the Quality of Medicines and Healthcare (EDQM)
http://www.edqm.eu/site/page_628.html

European Generic Medicines Association (EGA)
http://www.egagenerics.com

European Federation of Pharmaceutical Industries and Associations (EFPIA)
http://www.efpia.org

European Pharmaceutical Legislation
http://www.ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

Heads of Medicines Agencies (HMA)
http://www.hma.eu

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
http://www.ich.org

International Federation of Pharmaceutical Manufacturers and Associates (IFPM)
http://www.ifpma.org

nCADREAC – New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern European Countries 
http://www.newcadreac.org/cadreac.html

Pharmaceutical Information & Pharmacovigilance Association
http://www.aiopi.org.uk

The Organisation for Professionals in Regulatory Affairs (TOPRA)
http://www.topra.org

The Proprietary Association of Great Britain
http://www.pagb.org.uk 

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