Las industrias farmacéuticas y la biofarmacéutica exigen una gran transparencia a lo largo de la cadena de suministro. Por ello, existe una creciente demanda de disponer de documentación completa sobre las materias primas suministradas a este sector.

Nuestro equipo de calidad ofrece soporte reglamentario específico para todos nuestros productos, tanto GMP como no GMP.

Con toda esta documentación, ofrecemos:

  • Registro rápido.
  • Cumplimiento de normas regulatorias internacionales.
  • Apoyo regulatorio para nuestros clientes.
  • Información transparente de la cadena de suministro.

Para los APIs, ofrecemos:

  • CEP (Certificate of Suitability of the European Pharmacopeia).
  • ASMF (Active Substance Master Files).

Todos estos documentos pueden ser proporcionados en formato e-CTD.

CEP & ASMF disponibles:

ProductCAS No.CodeKilolabAPIEU ASMFCEPUS ASMF
L(+)-Tartaric acid GMP87-69-4381414NOyesX
Calcium hydrogenphosphate anhydrous GMP7757-93-9383410NOyesX
Cinc oxide GMP1314-13-2304814NOyesXX
Copper (II) oxide GMP1317-38-0352702NOyesX
Copper (II) sulfate anhydrous GMP7758-98-7382914NOyesX
Copper II sulphate 5-hydrate GMP7758-99-8380214NOyesX
Copper(II) hydroxicarbonate(Malaquita) GMP12069-69-1353510NOyesXX
Magnesium bromide 6-hydrate GMP QP16674-78-5385610NOyesX
Magnesium fluoride GMP QP16674-78-5385710YESyesX
Magnesium hydroxide GMP1309-42-8384514NOyesX
Magnesium L-lactate 2-hydrate GMP18917-93-6353414NOyesX
Manganese carbonate precipitated GMP598-62-9352310NOyesXX
Phenol GMP108-95-2352610NOyesX
Potassium bromide GMP7758-02-3351814NOyesX
Potassium chlorate GMP3811-04-9384610NOyesX
Sodium dihydrogen phosphate anhydrous GMP USP7558-80-7382015NOyesX
Sodium dihydrogenphosphate 1-hydrate GMP10049-21-5351015NOyesX
Sodium fluoride GMP PH7681-49-4353314yesR0-CEP 2016-103-Rev 01
Sodium molybdate 2-hydrate GMP QP10102-40-6387610yesXX
Sodium molybdate 2-hydrate GMP PH10102-40-6387614yesXX
Sodium selenite GMP PH10102-18-8352514yesXXX
Succinic acid110-15-6382216yesXX
Tri-sodium citrate 2-hydrate GMP6132- 04- 3383243yesXX
Urea GMP57-13-6381114yesXXX
Chromium (III) chloride 6-hydrate GMP USP10060-12-5354315yesXX
Cobalt (II) chloride 6-hydrate GMP QP7791-13-13860yesXX
Potassium iodate GMP FCC7758- 05- 6386811yesXX

Para los excipientes, materias primas y reactivos ofrecemos los siguientes dossiers:

  • Technical Package: precio 500€
  • Dossier básico: gratuito
CTD
Module
3 Index		DescripciónASMF
12.000€		Technical
package
500€		Basic
free of
charge
PRODUCT
QUALITY
SELF-
ASSESMENT		NANA
SUPPLY
CHAIN
INFORMATION		NA
(only if GMP. Condition: CDA)		NA
3.2.S.1GENERAL
INFORMATION
3.2.S.1.1NOMENCLATURE
3.2.S.1.2STRUCTURE
3.2.S.1.3GENERAL
PROPERTIES
3.2.S.2MANUFACTURE
3.2.S.2.1MANUFACTURER
3.2.S.2.2DESCRIPTION
OF
MANUFACTURING
PROCESS		flow chart simple
3.2.S.2.3CONTROL
OF
MATERIALS		NANA
3.2.S.2.4CONTROL
OF
CRITICAL
STEPS		NANA
3.2.S.2.5PROCESS
VALIDATION
AND/OR
EVALUATION		NANA
3.2.S.2.6MANUFACTURING
PROCESS DEVELOPMENT		NANA
3.2.S.3CHARACTERISATION
3.2.S.3.1ELUCIDATION
OF
STRUCTURE
SND OTHER
CHARACTERISTICS		NANA
3.2.S.3.2IMPURITIESICH Q3DTSE/BSE+ allergens+ Halal+ kosher+ etc.
3.2.S.4CONTROL
OF DRUG
SUBSTANCE
3.2.S.4.1SPECIFICATION
3.2.S.4.2ANALYTICAL
PROCEDURES
List of methods
3.2.S.4.3VALIDATION
OF
ANALYTICAL
PROCEDURES		NANA
3.2.S.4.4BATCH
ANALYSIS
3.2.S.4.5JUSTIFICATION
OF
SPECIFICATION
3.2.S.5REFERENCE
STANDARDS OF
MATERIALS		NA
3.2.S.6CONTAINER
CLOSURE
SYSTEM
3.2.S.7STABILITY
3.2.S.7.1STABILITY
SUMMARY AND
CONCLUSIONS		If available: 1000€ extra costRetest date justification
3.2.S.7.2POST-APPROVAL
STABILITY PROTOCOL
AND STABILITY
COMMITMENT		NANA
3.2.S.7.3STABILITY
DATA		NANA
only for the restricted part

Certificados GMP

Tenemos disponibles certificados GMP de AEMPS (Spanish Agency of Medicines and Medical Devices) para todos nuestros APIs.