Business Services

NJK & Associates, Inc. NJK & Associates, Inc.- A collaborative group of industry consultants serving the medical device and IVD industry. NDA NDA- NDA is a European regulatory affairs and patient safety consultancy. Lorenz LIfe Sciences Lorenz LIfe Sciences- Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies. HIPAA Exams, Inc. HIPAA Exams, Inc.- Online HIPAA training course and testing for healthcare professionals. Global Regulatory Services Global Regulatory Services- Regulatory affairs services for the pharmaceutical, herbal, and biotech industries. HIPAATraining.com HIPAATraining.com- Online self paced HIPAA training and compliance do-it-yourself kits. QualiMedd QualiMedd- An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics. Abnovo Ltd Abnovo Ltd- Specialize in regulatory consulting and authorized representation in the European Union. MEDIcept MEDIcept- MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. xFDA Inc. xFDA Inc.- Provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory. Zodiac Pharmaceutical Services Zodiac Pharmaceutical Services- Provides consulting services in the areas of patent, regulatory affairs, marketing research, and QA/GMP documentation for small to medium size phar… Cyton Biosciences Ltd. Cyton Biosciences Ltd.- European regulatory affairs consultancy providing specialist product development and registration services. IMI Consulting GmbH IMI Consulting GmbH- IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acqu… Global Quality Alliance, LLC Global Quality Alliance, LLC- Team of GMP consultants and quality auditors that provide consulting, auditing, and training to the pharmaceutical, biotechnology, API, dietary suppl… Shafi Consultancy Shafi Consultancy- Firm specializing in providing SAS training and expertise in working with clinical trials. Jim Colyn & Associates Quality Consultants, LLC Jim Colyn & Associates Quality Consultants, LLC- Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procure… Kennedy Writing Service (KWS) Kennedy Writing Service (KWS)- Medical writing and proofreading company. PharmaReady PharmaReady- A fully integrated web-based eDMS and eCTD Submissions Solution Suite. Infonetica Infonetica- GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. Abrimed Abrimed- Regulatory affairs consultants for ISO, GMP, and FDA compliance Veirup Consult Veirup Consult- Danish regulatory affairs consultancy International Regulatory Business Consultants, L.L.C. International Regulatory Business Consultants, L.L.C.- Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device… FarmavitaR+ FarmavitaR+- Professional network of regulatory affairs consultants and professionals. GLP Quality Consulting, LLC GLP Quality Consulting, LLC- Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. MarcM Consulting Canada MarcM Consulting Canada- Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical resea… Computer System Validation Computer System Validation- Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Sigma Biomedical Sigma Biomedical- Supports biomedical research and medical device development by providing custom solutions. Tumont Limited Tumont Limited- Specializes in providing cGxP equipment and software validation support to pharmaceutical laboratories in UK. They can provide plans, protocols, reports, SOPs, inv… Exalon Exalon- Specialized on eCTD submissions. Qarad Qarad- Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. Kobridge Consulting Ltd Kobridge Consulting Ltd- Quality and regulatory services to register medical devices in different markets. Supplier audits in Asia. Based in Korea. Mandell Horwitz Consultants LLC Mandell Horwitz Consultants LLC- Regulatory and scientific consulting for medical devices and other FDA-regulated products. Cabridge Regulatory Services Cabridge Regulatory Services- Specialists in the field of pharmaceutical regulatory affairs. CIMCON Software, Inc. CIMCON Software, Inc.- Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. Strategic Compliance International, Inc. Strategic Compliance International, Inc.- Specializes in regulatory compliance consulting for biologics, medical devices and drug companies. QSite QSite- Consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality as… Arham Consultants.com Arham Consultants.com- Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - and NPPA - National Pharmac… TDC Software TDC Software- Engineering software suite covering risk management. Draco Associates Ltd. Draco Associates Ltd.- Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other … Pharmaceutical Development Group Pharmaceutical Development Group- Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovi… TRAC Services TRAC Services- A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. Ceutical Labs Ceutical Labs- Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product develop… PinneyAssociates PinneyAssociates- Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter s… Lionpharm Regulatory Consulting GmbH Lionpharm Regulatory Consulting GmbH- Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal … Kemic Bioresearch Kemic Bioresearch- Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). Pharma-EU s.r.o. Pharma-EU s.r.o.- Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. Gamp Forum Gamp Forum- Bio-Pharma professionals forum. Comply Comply- Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, st… Qserve Group Qserve Group- Provides CE marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) a… Quality Vectors Quality Vectors- Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.