Documentation
We help in maintaining QMS Documents.
- Standard Operating Procedures (SOPs) for all departments of pharmaceutical manufacturing units.
- Validation Protocols
- QMS Documents
- IQ, OQ, PQ of all instruments/equipment
- Audit Checklists for all departments
Plant Setup
Our team will visit your site & understand what type of plant you want to set up. We then provide you map, provide the source of the machine, supervise construction & machine installation & in the end successfully get you the license. Pharmaguideline can provide complete consultancy to set up oral dosages and injectable plants.
- Oral Dosages Plant
- Injectable Plant
Regulatory Compliance
Pharmaguideline can help you prepare entire technical document for drug product registration in various countries all over the world.
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Investigational New Drug Application (IND)
- CTD Dossier
- GMP Audit/ Gap Analysis/ Gap Closures services
- Regulatory Compliance Services
Training
- cGMP/GLP/GDP
- Computer System Validation
- Data Integrity
- Quality Risk Management
- Audit behavior/FDA audit readiness
- AMD, AMV, AMT
- Cleaning Validation /Process validation
- CAPA
- Investigations
- Technology Transfer/Stability Study
- Human Error/Quality culture development
- On-demand training as per customer requirement
We are experienced pharmaceutical consultants and our pharma consultancy services are in above mentioned areas including regulatory consulting services as a regulatory compliance consultant.