Regulatory Affairs

We work closely with our clients to define the goals and objectives of drug development and registration, and to develop and submit the appropriate documents to the regulatory authorities on time.

Pierrel Research has many years of hands-on experience with national and European centralized and mutual recognition procedures, and offers a complete set of services required to further the development or your medicinal products to obtain product marketing authorizations in the European Union, the US and Switzerland.

Note that since the company has certain authorizations we are able to offer manufacturing related services as part of our regulatory services.

Experience

The professional staff at Pierrel Research has obtained more than 300 product licences, both national and EU-wide. In addition, both registrations and re-registrations have been successfully made on behalf of sponsors. During the last 5 years we have worked with 103 substances. Pierrel Research's regulatory staff have organised and conducted a number of Scientific Advice Meetings with the EMEA and IND meetings with the FDA (pre-IND and End-of-Phase 2 meetings).

Services we offer either individually or as a complete package include:

• Consultancy in all questions regarding drug development and drug regulatory affairs
• Development of drug development and registration strategies
• Preparation and conduct of Scientific Advice Meetings (USA and Europe)
• All contacts with the authorities for approved drugs, acting on behalf of the sponsor as their Regulatory Affairs department
• Choice of Reference Member States in cases of Mutual Recognition and Decentralised Procedures
• Dossier structuring and preparation of CTD modules 1 - 5 including eCTDs
• Summaries/Overviews on quality (chemical/pharmaceutical/ biological part), safety (pharmaco/toxicological part), and efficacy (clinical part)
• CES (clinical expert statement)
• Clinical Trial / IND applications for Europe and USA
• Readability testing of patient information leaflets
• Provison of Qualified Persons for control and manufacturing process (QP, QPPV)
• Re-registrations and registration renewals
• All kinds of variations (Type I, Type II)
• Pharmacovigilance services including setup of a validated safety database
• PSUR preparation and updating
• Legal representative for sponsors not established in the European Union