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:

CODEPRODUCTASMFCEP
383410Calcium hydrogenphosphate anhydrous GMP
341414Cinc acetate 2-hydrate (parenteral) GMP
352702Copper (II) oxide GMP
382914Copper (II) sulfate anhydrous GMP
380214Copper II sulphate 5-hydrate GMP
353510Copper(II) hydroxicarbonate(Malaquita) GMP
340010Di-sodium hydrogenphosphate 12-hydrate GMP
381414L(+)-Tartaric acid
340710Magnesium acetate 4-hydrate (parenteral) GMP
384514Magnesium hydroxide GMP
353414Magnesium L-lactate 2-hydrate GMP
352310Manganese carbonate precipitated GMP
352610Phenol GMP
340514Potassium acetate (parenteral) GMP
351814Potassium bromide GMP
384610Potassium chlorate GMP
350714Potassium dihydrogenphosphate GMP PH
340414Sodium acetate 3-hydrate (parenteral) GMP
382015Sodium dihydrogen phosphate anhydrous GMP USP
351015Sodium dihydrogenphosphate 1-hydrate GMP
340114Sodium dihydrogenphosphate 2-hydrate (parenteral) GMP
353314Sodium fluoride GMP
354010Sodium molybdate 2-hydrate GMP
352514Sodium selenite GMP
380710Sodium sulfate 10-hydrate GMP
381114Urea GMP
304814Zinc Oxide gmp PH

For the excipients, starting material and reagents we offer the following dossiers

  • Technical package for €500
  • Basic dossier free of charge
CTD
Module
3 Index
DescriptionASMF
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
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

GMP Certificates

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

We also have GMP certificates from external audit companies such as Forum Auditorias and NQA for our factories.