Regulatory Affairs

International and Local Expertise in regulatory compliance is the starting point of 2GL’s quality services. 2GL is experienced in the regulatory requirements and environment of each of the countries in which it operates. By having  knowledge of local customs and connections to drug regulatory agencies, 2GL is able to streamline the regulatory process for clinical trial approvals in the shortest time possible, which translates to faster patient enrollment for our clients.

2GL’s regulatory activities include certified translations, regulatory package assembly and submission, cGCP training and audits, and SOP development and review.

2GL has a centralized regulatory filing procedure and all regulatory documents are filed at 2GL’s offices under strict confidentiality. All regulatory documents are maintained, updated, audited and archived according to cGCP and ICH  guidelines. Additionally, 2GL has standard operating procedures (SOPs) in place for all aspects of clinical trial conduct which are reviewed and updated on a regular basis.

We offer services that can reduce the registration process and obtaining a drug license for our clients.

Marketing authorization of medicinal products

a) Completeness of the documentation for the registration of medicinal products

b) Evaluation of the documentation for the registration of medicinal products

Post-marketing activities regarding medicinal products

a) Renewal of the marketing authorization of the medicinal products

b) Variations

c) Medicinal product advertising

d) Pricing and reimbursement