Regulatory Consulting
Technical review and documentation support for pharmaceutical dossiers.
From brief to delivery
Research
Define the product and technical requirements.
Pre-formulation
Compatibility screening and physicochemical characterization.
Development
Formulation and process development.
Analytical validation
Analytical method development and validation.
Scale-up
Support progression from laboratory to pilot scale.
Process validation
Validation protocols and process optimization.
Technology transfer
Transfer dossiers, master batch records and stability data.
Commercial support
Manufacturing coordination and regulatory filing support.
Explore our technical services
Formulation Development
Development support for solid dosage forms, liquids, injectables, pellets and complex delivery systems.
Explore service ↗Technology Transfer
A structured bridge between product development and manufacturing.
Explore service ↗Audit Management
Preparation, evaluation and remediation support for quality systems.
Explore service ↗Vendor Qualification Audits
Technical evaluation of raw-material manufacturers, KSM suppliers and contract testing laboratories.
Explore service ↗Data Integrity & ALCOA+ Remediation
Data-governance reviews for laboratory and manufacturing systems.
Explore service ↗Regulatory Dossier Support
Compilation and technical gap analysis for regulatory documentation.
Explore service ↗DMF Review
Drug Master File review and gap analysis.
Explore service ↗CEP Support
Technical documentation support for Certificates of Suitability.
Explore service ↗CTD / ACTD Support
Structured review of regulatory dossiers.
Explore service ↗Inspection Readiness
Prepare teams and documentation for regulatory inspections.
Explore service ↗Mock Audits
Practice inspections to identify quality-system gaps.
Explore service ↗CAPA Systems
Corrective and preventive action planning.
Explore service ↗Supply Chain & GDP
Distribution practices, traceability and handling coordination.
Explore service ↗Warehouse Temperature Mapping
Assess temperature distribution in storage areas.
Explore service ↗Cold Chain Validation
Support for temperature-sensitive supply chains.
Explore service ↗Looking for a specific API, formulation or technical solution?
Share your product, quantity and documentation requirements. Let’s take the next step together.