The pharma and biopharmaceutical industry calls for increasing transparency along the supply chain. There is growing demand to have complete documentation about the raw materials supplied in this sector.
Our regulatory team offers you dedicated regulatory support for all our GMP and non-GMP products.
With all this documentation we offer:
- Shorter registration phase
- Compliance with international regulatory standards
- Dedicated regulatory support
- Transparent supply chain information
For APIs we offer:
- CEP Certificate of Suitability of the European Pharmacopeia
- ASMF Active Substance Master Files
All these documents can be provided in e-CTD format
CEP & ASMF available:
| Product | CAS No. | Code | EU ASMF | CEP | US DMF |
|---|---|---|---|---|---|
Acetic Acid 80% w/w GMP | 64-19-7 | 384110 |  | ||
Ammonium chloride GMP | 12125-02-9 | 350314 | R0-CEP 2021-326-Rev 00 | ||
Ammonium molybdate 4 hydrate GMP | 12054-85-2 | 386915 | | ||
Antimony potassium tartrate GMP | 28300-74-5 | 388715 | | ||
Calcium acetate anhydrous GMP | 62-54-4 | 382110 | | ||
Calcium hydrogenphosphate anhydrous GMP | 7757-93-9 | 383410 | | ||
Chromium (III) chloride 6-hydrate GMP | 10125-13-0 | 388115 | | ||
Zinc acetate 2-hydrate GMP | 5970-45-6 | 351244 | R0-CEP 2018-177-Rev 01 | ||
Zinc oxide GMP | 1314-13-2 | 304814 | | |
|
Cobalt (II) chloride 6-hydrate GMP | 7791-13-1 | 386010 | | ||
Copper (II) Chloride 2-hydrate GMP | 10125-13-0 | 387843 | | ||
Copper (II) oxide GMP | 1317-38-0 | 352702 | | ||
Copper II sulphate 5-hydrate GMP | 7758-99-8 | 380214 | | ||
Copper(II) hydroxicarbonate(Malaquita) GMP | 12069-69-1 | 353510 | | |
|
Di-sodium hydrogenphosphate 12-hydrate GMP | 10039-32-4 | 351544 | CEP 2017-233-Rev 02 | ||
EDTA, iron (III) sodium salt 3-hydrate | 18154-32-0 | 333310 | | ||
Iron (III) chloride sol. 10-14% GMP | 7705-08-0 | 382337 | | ||
L(+)-Tartaric acid GMP | 87-69-4 | 381414 | | ||
Magnesium acetate 4-hydrate (parenteral) GMP | 16674-78-5 | 353042 | R0-CEP 2017-280-Rev 00 | ||
Magnesium bromide 6-hydrate GMP | 16674-78-5 | 385610 | | ||
Magnesium fluoride GMP | 16674-78-5 | 355510 | | ||
Magnesium hydroxide GMP | 1309-42-8 | 384514 | | ||
Magnesium L-lactate 2-hydrate GMP | 18917-93-6 | 353414 | | ||
Manganese carbonate precipitated GMP | 598-62-9 | 352310 | | |
|
Manganese (II) chloride 4-hydrate GMP | 13446-34-9 | 354115 | | ||
Nickel sulfate 6-hydrate GMP | 10101-97-0 | 387543 | | ||
Phenol GMP | 108-95-2 | 352610 | | ||
Potassium acetate GMP | 127-08-2 | 387144 | CEP 2018-028-Rev 01 | ||
Potassium bromide GMP | 7758-02-3 | 351814 | | ||
Potassium bromide GMP Crystal. | 7758-02-3 | 371414 | | ||
Potassium chlorate GMP | 3811-04-9 | 384610 | | ||
Potassium iodate GMP | 7758-05-6 | 386811 | | ||
Sodium acetate 3-hydrate GMP | 6131-90-4 | 350944 | CEP 2018-100-Rev 01 | ||
Sodium dihydrogen phosphate anhydrous GMP | 7558-80-7 | 382015 | | ||
Sodium dihydrogenphosphate 1-hydrate GMP | 10049-21-5 | 351015 | | ||
Sodium dihydrogenphosphAte 2-hydrate GMP | 10028-24-7 | 351142 | CEP 2017-177-Rev 02 | ||
Sodium fluoride GMP | 7681-49-4 | 353314 | CEP R1-CEP 2016-103-Rev 00 | ||
Sodium molybdate 2-hydrate GMP | 10102-40-6 | 387614 | | ||
Sodium molybdate 2-hydrate GMP | 10102-40-6 | 387610 | | ||
Sodium selenite GMP | 10102-18-8 | 352514 | | |
|
Succinic acid GMP | 110-15-6 | 382216 | | ||
Tri-sodium citrate 2-hydrate GMP | 6132- 04- 3 | 383215 | |
||
Urea GMP | 57-13-6 | 381114 | |
For the excipients, starting material and reagents we offer the following dossiers
- Technical package
- Basic dossier
| CTD Module 3 Index | Description | ASMF | Technical package | Basic Dossier |
|---|---|---|---|---|
| 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: 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 | ||||
GMP Certificates
We have available GMP certificates from AEMPS (Spanish Agency of Medicines and Medical Devices) for all our APIs.
