Consulting for Regulatory Affairs, CMC and GXP for pharmaceutical, biotech and medical device companies

HORN Pharmaceutical Consulting

Bruchsal, GermanyNew on Amplifa

2002Founded

Sole proprietorshipLegal form, owner Dr. Hiltrud Horn

>32 yearsIndustry experience of the owner

BruchsalLocation, Baden-Württemberg

ABOUT HORN PHARMACEUTICAL CONSULTING

HORN Pharmaceutical Consulting is a consulting firm for the pharmaceutical and biotechnology industry, founded in 2002 by Dr. Hiltrud Horn and based in the center of Bruchsal, Baden-Württemberg. The company offers regulatory and business consulting across the entire spectrum of product development: from early development phases and clinical trials to the submission of marketing authorization dossiers. Its services include Regulatory Affairs (regulatory strategies, authority meetings with EMA, FDA and national authorities, dossier submissions), the preparation and review of CMC documents such as IMPD/IND, CTD for MAA/NDA, ASMF, US-DMF and CEP, GXP consulting (GMP/GCP/GLP, SOP creation, QA systems, mock inspections), Clinical Development, Due Diligence projects and training. The team consists of internationally experienced specialists who handle both small and large projects in all phases of the product life cycle: from pre-submission through approval to the post-approval phase. Clients come from the pharmaceutical industry, biotechnology, the medical device sector, API manufacturers, contract manufacturers, contract laboratories, SMEs as well as the Advanced Therapy Industry.

Site: Bruchsal
Processes: Regulatory Affairs and CMC consulting (dossier preparation: IMPD/IND, CTD for MAA/NDA, ASMF, US-DMF,, GMP/GCP/GLP compliance consulting, SOP creation, QA systems, mock inspections, Due Diligence, project management, regulatory intelligence, training, Regulatory Affairs (strategies, authority meetings, dossier submission), CMC documents (IMPD/IND, CTD for MAA/NDA), Project Management, GXP consulting (GMP/GCP/GLP, SOPs, compliance checks, mock inspections), Clinical Development (IB, Study Protocol/Report, Clinical Overviews)
Materials: Small molecules, Peptides, Antibodies, Proteins, Vaccines, Biotissue, Small Molecules, Biotissue & somatic cell therapies (Advanced Therapies)
Certificates: GMP/GCP/GLP compliance consulting, Mock inspections (FDA/EMA preparation), QA system planning and installation, ISO 9001 (not documented)
Founded: 2002
Industries: Pharmaceutical Industry, Biotechnology, Medical Devices, API Manufacturers, Contract Manufacturers, Contract Laboratories

01
Regulatory strategy development
02
Preparation of CMC and regulatory documents
03
Submission to authorities (EMA, FDA, national authorities)
04
GXP compliance and QA systems
05
Post-approval phase support

PRODUCT CLASSES & CONSULTING FOCUS AREAS

Small Molecules

Consulting on CMC requirements and regulatory dossiers for small-molecule active substances.

PEP

Peptides

Specialized CMC and regulatory consulting for peptide active substances.

Antibodies

Consulting for biological products including antibodies in the context of CTD and BLA.

PROT

Proteins

CMC documentation and regulatory support for protein-based products.

VAC

Vaccines

Consulting on development-specific CMC requirements for vaccines.

Biotissue & somatic cell therapies (Advanced Therapies)

Experience and know-how for advanced therapy products such as biotissues and somatic cell therapies.

LOCATION

Bruchsal

Office/Headquarters

Industries

Pharmaceutical IndustryBiotechnologyMedical DevicesAPI ManufacturersContract ManufacturersContract LaboratoriesSMEsAdvanced Therapy Industry (ATI)Medical EquipmentContract ManufacturerAdvanced Therapy Industry

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Regulatory Affairs and CMC consulting (dossier preparation: IMPD/IND, CTD for MAA/NDA, ASMF, US-DMF,Engineering	–	–	–	–	–
GMP/GCP/GLP compliance consulting, SOP creation, QA systems, mock inspectionsTesting	–	–	–	–	–
Due Diligence, project management, regulatory intelligence, trainingEngineering	–	–	–	–	–

Additional services

Regulatory Affairs (strategies, authority meetings, dossier submission)CMC documents (IMPD/IND, CTD for MAA/NDA)Project ManagementGXP consulting (GMP/GCP/GLP, SOPs, compliance checks, mock inspections)Clinical Development (IB, Study Protocol/Report, Clinical Overviews)Due DiligenceTraining (Regulatory Affairs, GMP, GCP, GLP)Regulatory IntelligencePreparation of ASMF, US-DMF, CEPMedical Writing (SPCs, QOS, CMC documents)

QUALITY & COMPLIANCE

The consulting includes support with GMP/GCP/GLP compliance, the planning and execution of mock inspections to prepare for authority inspections (FDA, EMA, national authorities), as well as the establishment and optimization of QA systems including GAP analyses and corrective action plans.

Evidence	Bruchsal
GMP/GCP/GLP compliance consulting
Mock inspections (FDA/EMA preparation)
QA system planning and installation
ISO 9001 (not documented)

HISTORY

2002
Foundation of HORN Pharmaceutical Consulting by Dr. Hiltrud Horn in Bruchsal