Business

Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.

Quality and regulatory services to register medical devices in different markets. Supplier audits in Asia. Based in Korea.

Offers consultancy services to prevent and resolve compliance problems and to develop strategies for the submission and approval of drugs, biologics, and devices.

Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.

Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe.

Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies.

Helps life science companies analyze and improve the quality of their research laboratories and production environments, playing a focused role in the development and delivery of leading drugs and devices used to improve patients' lives.

European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.

A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.

Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available.

MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting.

Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.

MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe.

Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.

NDA is a European regulatory affairs and patient safety consultancy.

A collaborative group of industry consultants serving the medical device and IVD industry.

Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.

Provides quality and regulatory consulting and training for medical device and IVD manufacturers. Specializing in ISO 13485 and FDA QSR compliance, 510(k) submissions, form 483 and warning letter responses, CAPA programs, and CE mark approval.

Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies.

Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.

Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.

Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and cGMP inspections.

Provide clinical and regulatory support of all phases of global drug development with operations in over 80 countries on all continents.

A fully integrated web-based eDMS and eCTD Submissions Solution Suite.

Engineering software suite covering risk management.

Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy.

Validated labeling systems and inventory management software systems designed specifically for FDA 21 CFR Part 11 regulated environments.

EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments.

Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories.

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) and production registration as well as other regulatory services.

QFI is a European based consultancy providing CE marking services, EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity Assessment support and compliance audits

Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance.

Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada.

A management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971.

Provides international regulatory solutions to the pharmaceutical and biologics industries.

RAA (regulatory affairs consultancy)

Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy.

Provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development.

Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical writing for medicinal products.

Specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries.

Firm specializing in providing SAS training and expertise in working with clinical trials.

Supports biomedical research and medical device development by providing custom solutions.

Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development.

Works to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations.

A consulting firm specializing in regulatory affairs for medical device manufacturing.

Specializes in regulatory compliance consulting for biologics, medical devices and drug companies.

Provides HIPAA training courses in multiple formats both onsite and online.

Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.

Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.

Thermal mapping and autoclave validation