Consulting
- 321
- MarcM Consulting Canada
- Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical research/trials, bioequivalence studies, and DMF preparations. Regulatory and business development services offered in English, Portuguese, and Spanish.
- 322
- Marion Weinreb and Associates, Inc.
- Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
- 323
- Masy Systems
- Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
- 324
- Med Device Advisors
- Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available.
- 325
- Medcon Taiwan, Inc.
- A Taiwan-based regulatory affairs consultant to the medical and life science industry
- 326
- Medius AG
- Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
- 328
- NJK & Associates, Inc.
- NJK & Associates are a collaborative group of industry consultants serving the medical device and IVD industry.
- 329
- OMSBAR
- OMSBAR provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management, verification and validation, and maintains a core staff of experienced medical device personnel.
- 330
- Obelis European Authorized Representative Center
- Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
- 332
- Oracle Consulting Group
- Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training
- 333
- Pennington Pharmaceutical Services LLC
- Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies.
- 334
- Perseus Partners
- Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
- 335
- Pharma-EU s.r.o.
- Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.
- 337
- Pharmalink Consulting
- For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
- 338
- Q-NET LLC
- 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.