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:
Product | CAS No. | Code | Kilolab | API | EU ASMF | CEP | US ASMF |
---|---|---|---|---|---|---|---|
L(+)-Tartaric acid GMP | 87-69-4 | 381414 | NO | yes | X | ||
Calcium hydrogenphosphate anhydrous GMP | 7757-93-9 | 383410 | NO | yes | X | ||
Cinc oxide GMP | 1314-13-2 | 304814 | NO | yes | X | X | |
Copper (II) oxide GMP | 1317-38-0 | 352702 | NO | yes | X | ||
Copper (II) sulfate anhydrous GMP | 7758-98-7 | 382914 | NO | yes | X | ||
Copper II sulphate 5-hydrate GMP | 7758-99-8 | 380214 | NO | yes | X | ||
Copper(II) hydroxicarbonate(Malaquita) GMP | 12069-69-1 | 353510 | NO | yes | X | X | |
Magnesium bromide 6-hydrate GMP QP | 16674-78-5 | 385610 | NO | yes | X | ||
Magnesium fluoride GMP QP | 16674-78-5 | 385710 | YES | yes | X | ||
Magnesium hydroxide GMP | 1309-42-8 | 384514 | NO | yes | X | ||
Magnesium L-lactate 2-hydrate GMP | 18917-93-6 | 353414 | NO | yes | X | ||
Manganese carbonate precipitated GMP | 598-62-9 | 352310 | NO | yes | X | X | |
Phenol GMP | 108-95-2 | 352610 | NO | yes | X | ||
Potassium bromide GMP | 7758-02-3 | 351814 | NO | yes | X | ||
Potassium chlorate GMP | 3811-04-9 | 384610 | NO | yes | X | ||
Sodium dihydrogen phosphate anhydrous GMP USP | 7558-80-7 | 382015 | NO | yes | X | ||
Sodium dihydrogenphosphate 1-hydrate GMP | 10049-21-5 | 351015 | NO | yes | X | ||
Sodium fluoride GMP PH | 7681-49-4 | 353314 | yes | R0-CEP 2016-103-Rev 01 | |||
Sodium molybdate 2-hydrate GMP QP | 10102-40-6 | 387610 | yes | X | X | ||
Sodium molybdate 2-hydrate GMP PH | 10102-40-6 | 387614 | yes | X | X | ||
Sodium selenite GMP PH | 10102-18-8 | 352514 | yes | X | X | X | |
Succinic acid | 110-15-6 | 382216 | yes | X | X | ||
Tri-sodium citrate 2-hydrate GMP | 6132- 04- 3 | 383243 | yes | X | X | ||
Urea GMP | 57-13-6 | 381114 | yes | X | X | X | |
Chromium (III) chloride 6-hydrate GMP USP | 10060-12-5 | 354315 | yes | X | X | ||
Cobalt (II) chloride 6-hydrate GMP QP | 7791-13-1 | 3860 | yes | X | X | ||
Potassium iodate GMP FCC | 7758- 05- 6 | 386811 | yes | X | X | ||
Para los excipientes, materias primas y reactivos ofrecemos los siguientes dossiers:
- Technical Package: precio 500€
- Dossier básico: gratuito
CTD Module 3 Index | Descripción | ASMF 12.000€ | Technical package 500€ | Basic free of charge |
---|---|---|---|---|
PRODUCT QUALITY SELF- ASSESMENT | NA | ![]() | NA | |
SUPPLY CHAIN INFORMATION | NA | ![]() (only if GMP. Condition: CDA) | NA | |
3.2.S.1 | GENERAL INFORMATION | |||
3.2.S.1.1 | NOMENCLATURE | ![]() | ![]() | ![]() |
3.2.S.1.2 | STRUCTURE | ![]() | ![]() | ![]() |
3.2.S.1.3 | GENERAL PROPERTIES | ![]() | ![]() | ![]() |
3.2.S.2 | MANUFACTURE | |||
3.2.S.2.1 | MANUFACTURER | ![]() | ![]() | ![]() |
3.2.S.2.2 | DESCRIPTION OF MANUFACTURING PROCESS | ![]() | ![]() | flow chart simple |
3.2.S.2.3 | CONTROL OF MATERIALS | ![]() | NA | NA |
3.2.S.2.4 | CONTROL OF CRITICAL STEPS | NA | NA | |
3.2.S.2.5 | PROCESS VALIDATION AND/OR EVALUATION | ![]() | NA | NA |
3.2.S.2.6 | MANUFACTURING PROCESS DEVELOPMENT | ![]() | NA | NA |
3.2.S.3 | CHARACTERISATION | |||
3.2.S.3.1 | ELUCIDATION OF STRUCTURE SND OTHER CHARACTERISTICS | ![]() | NA | NA |
3.2.S.3.2 | IMPURITIES | ![]() | ICH Q3D | TSE/BSE+ allergens+ Halal+ kosher+ etc. |
3.2.S.4 | CONTROL OF DRUG SUBSTANCE | |||
3.2.S.4.1 | SPECIFICATION | ![]() | ![]() | ![]() |
3.2.S.4.2 | ANALYTICAL PROCEDURES | ![]() | ![]() | ![]() List of methods |
3.2.S.4.3 | VALIDATION OF ANALYTICAL PROCEDURES | ![]() | NA | NA |
3.2.S.4.4 | BATCH ANALYSIS | ![]() | ![]() | ![]() |
3.2.S.4.5 | JUSTIFICATION OF SPECIFICATION | ![]() | ![]() | ![]() |
3.2.S.5 | REFERENCE STANDARDS OF MATERIALS | ![]() | ![]() | NA |
3.2.S.6 | CONTAINER CLOSURE SYSTEM | ![]() | ![]() | ![]() |
3.2.S.7 | STABILITY | |||
3.2.S.7.1 | STABILITY SUMMARY AND CONCLUSIONS | ![]() | If available: 1000€ extra cost | Retest date justification |
3.2.S.7.2 | POST-APPROVAL STABILITY PROTOCOL AND STABILITY COMMITMENT | ![]() | NA | NA |
3.2.S.7.3 | STABILITY DATA | ![]() | NA | NA |
only for the restricted part |
Certificados GMP
Tenemos disponibles certificados GMP de AEMPS (Spanish Agency of Medicines and Medical Devices) para todos nuestros APIs.