The success of regulatory approvals is highly dependent upon the quality of the data submitted. Preparing a registration submission should not be an administrative exercise intended simply to assemble the appropriate documents into the format laid down by the relevant guidelines. The evaluation is based on both scientific considerations and administrative aspects such as layout and presentation of the data, taking into account relevant current guidelines.
This allows an early start to be made in planning the work needed to finalise the registration package.
During preclinical and early clinical phases, a review of the historical data is crucial to future planning.

Evaluate technical data (chemistry/manufacturing, preclinical, clinical), to help determine the appropriate regulatory procedure and legal status for products
Propose optimal filing and submission strategy
Establish frequent contact with regulatory authorities to facilitate compliance

We can provide a comprehensive due diligence for all regulatory matters in mergers and acquisitions. Due diligence reports are tailored to client requirements, and subsequent meetings are held to ensure all investment questions are answered. We can assist the subject company's understanding of the regulatory requirements, allowing them to resubmit updated information.

Meetings are often necessary to discuss significant regulatory and/or development aspects of a new drug product.
We can assist in developing, assembling and reviewing your meeting request package, and initiate contact with agencies on your behalf. We can then be your intermediary should any questions arise or additional data be required. We attend meeting with Agencies.

We support your development activities and carry out projects
We take care of the entire project coordination in order to ensure regulatory compliance.

Our consolidate network of partners in EU countries and a local Agent in USA allow us to support our clients facing specific local issues.