Regulatory Submissions

LCR provides expert regulatory services for pharmaceuticals, medical devices or combination products. Submissions are conducted by professionals with excellent knowledge of local regulatory requirements.

This enables us to ensure effective procedures leading to timely study start-up. LCR provides regulatory consulting and submission either as a customized service or as a part of full service clinical trials.

Regulatory affair services include:

• Preparation of locally adapted essential documents for initial submission to the regulatory authority and concerned Ethics Committees.
• Interaction and follow-up with the regulatory authority and Ethics Committees.
• Obtaining local insurance policies.
• Contract negotiations.
• Document translations with expert revisions.
• Tracking submissions and safeguarding of timely filing of documents.