Globiox’s team of consultants collectively, have experience in navigating regulatory pathways for a variety of life sciences products including drugs, medical devices, and combination products in both the United States and the European Union.  The regulatory landscape is constantly evolving, and Globiox prides itself on staying in tune with the latest developments.  Here is a sample of the regulatory pathways we have worked with:

Drugs

a. United States-FDA

i. Investigational New Drug Applications (IND) for clinical trials

ii. New Drug Applications (NDA)

iii. Abbreviated New Drug Applications (ANDA)

iv. 505(b)(2) Applications

b. European Union-EMA

i. Single Marketing Authorization Applications

ii. Request for Authorization for Clinical Trials under the Clinical Trial Directive, and when in place, the Clinical Trial Regulation

Medical Devices

a. United States-FDA

i. Investigational Device Exemptions (IDE)

ii. 510k Pre Market Notifications

iii. De Novo Pathway

iv. Pre Market Approval (PMA)

b. European Union-Applicable Council Directive

i. Technical File Preparation to obtain CE Mark

ii. Design Dossier Preparation to obtain CE Mark

In the case of combination products, the regulatory pathway will vary depending on the nature of the combination product.


In most cases, companies need quality management systems in place in order to obtain regulatory approval for the products described above.  Globiox can provide support in developing quality management systems, from paper based, to electronic, and everything in between.  These systems can be designed to meet regulations and/or standards applicable to a company’s product including:

  1. US FDA regulations:

a. 21 CFR Parts 210 and 211 for drugs

b. 21 CFR Part 820 for medical devices

c. 21 CFR Part 11 for electronic records

2. European Union Regulations/Standards:

a. Commission Directive (EU) 2017/1572 for drugs

b. ISO13485, Medical Device Quality Management Systems, in order to meet the requirements of applicable regulations:

i. MDD 93/42/EEC; medical devices, through 2020

ii. AIMDD 90/385/EEC; implantable medical devices, through 2020

iii. IVDD 98/79/EC; invitro diagnostic devices, through 2020

iv. MDR 2017/745; medical devices and implantable medical devices after 2020

v. IVDR 2017/746; in vitro diagnostic devices after 2020