Contact information

Av Jaime Balmes 11 torre A piso 1 oficina 26 Col. Barrio San Marcos, México, C.P.

We are available 24/7.

55 4161 0060

clinical_solutions@scireclinical.com

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REGULATORY AFFAIRS

The constant regulatory changes in health matters by COFEPRIS, demands the intervention of highly qualified biologist pharmaceutical chemist specialized, with technical and scientific knowledge advanced, experience in applicable regulations and administrative processes of the regulatory agency involved.

The Scire Clinical Solutions work team studies each case intensively and comprehensively to issue the recommendations that allow the customer a better take decisions for a successful procedure before the Agencies Sanitary of interest.

Medical device services:

• Sanitary registrations, modifications and extensions.

i. Low risk.
ii. Class I, II and III.

• Ways of submission.

i. Ordinary.
ii. FDA, Health Canadá, Japón.

Medical device services:

• Sanitary registrations, modifications and extensions.

  i. Allopathic medicines.

  ii. Biotechnological.

  iii. Generic.

  iv. New molecules.

  v. Orphans.

  vi. Vitamins.

  vii. Herbalists.

Advertising services:

• Cosmetics.

• Medicines.

• Health services.

• Medical devices.