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:

ProductCAS No.CodeEU ASMFCEPUS DMF

Acetic Acid 80% w/w GMP

64-19-7

384110

Ammonium chloride GMP

12125-02-9

350314R0-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

351244R0-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

351544CEP 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

353042R0-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

387144CEP 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

350944CEP 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

351142CEP 2017-177-Rev 02

Sodium fluoride GMP

7681-49-4

353314CEP 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
DescriptionASMFTechnical
package
Basic
Dossier
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: 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

GMP Certificates

We have available GMP certificates from AEMPS (Spanish Agency of Medicines and Medical Devices) for all our APIs.