Our pharmaceutical regulatory consultants are here to assist you
- Manufacturing & laboratory equipment qualification and validation
- Computer system and software validation
- Development of validation master plans
- Test method / cleaning and process validation
- GMP, QA and QMS audits (FDA Parts 210 & 211)
- Data-Integrity Risk Assessments, including Part 11 and Annex 11
- New Drug and Abbreviated New Drug applications (Pre-IND, NDA and ANDA)
- Drug Master File assistance
- CMC document development
Quality & Regulatory Compliance Consulting
Avoid compliance gaps in your pharmaceutical manufacturing and regulatory processes.
Commissioning, Qualification, and Validation Consulting
You get direct access to CQV specialists with expertise in equipment commissioning, and validation support for new build pharmaceutical manufacturing or equipment moves.
Cleaning Validation
Keeping your drug products free from contamination risk.
Process Validation
Producing consistently acceptable drug products every time.
Equipment & Facility Qualification
Confirming suitability of critical systems at your facility.
Laboratory Validation
Ensuring laboratory test methods of the utmost integrity.
Computer System Validation
Safeguarding your electronic systems from bugs and cyber attacks.
Facility Temperature & Humidity Mapping
Evaluating whether drug products are stored under required conditions.