México, D. F. a 22 de octubre, 2007

IDRAC Database: Consultants – México

Independent Consultant
Offers consulting services in Mexican regulatory environment.

Christel G. Brüggemann S.
Sombrerete No. 499-3
Col. Hipódromo- Condesa
Tel: (52) 55 55-16-79-40
E-mail:c_bruggeman@yahoo.com.mx

Products and Services.

Regulatory Affairs: Regulatory consulting and advice for Mexican Ministry of Health dossier submission, assessing documents.
Review of foreign “Dossier’s” and adapting them for Registration in Mexico

Different Topics.
Elaboration of Quality Manuals.
Good documentation practices and documentation system
Instructor in GMP’s and related topics
Training of personal in GMP’s, GCP’s, Monitoring
Training of plant personal
Technical Consultant in GMP’s
Qualification of Designs for Pharmaceutical Plants
Validation