Pharma & Biotech Consultants
Specialized in providing services in :
- Cleaning Validation
- Method Validations
- Method Development
- Laboratory Investigations
- Laboratory Data Review
- Manufacturing Investigations
- Batch Manufacturing Record Review
- Regulatory Compliance
- cGMP Audit/Inspection
- Inspection Readiness Preparation
- Remediation Activities
- SOPs/ Protocols Drafting
Services we offer to our customers
Cleaning Validation
Cleaning Validation is the methodology used to assure that a cleaning process thoroughly removes ingredient residues and detergents from equipment used in the cleaning process. We specialize in chemical and microbial residues of both active and inactive ingredients used in product manufacturing. We provide consultancy services in the cleaning validation process either remotely or at the client site.
Analytical Method Validations
Analytical Method Validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose. We provide consultancy services including; the preparation of method validation protocol, execution of method validation at the client's site, and preparation of method validation report.
Analytical Method Development
The purpose of analytical method development is to establish the identity, purity, stability, bioavailability, potency, and physical characteristics of a drug. We provide consultancy services including literature search, feasibility, and development of analytical methods for assay, dissolution, and related compounds tests at the client site.
Laboratory Investigations
We provide consultancy services in investigating Out of Specification (OOS)/Out of Trend (OOT) test either remotely or at the client site.
Laboratory Data Review
We provide consultancy services in reviewing laboratory data for compliance either remotely or at the client site.
Manufacturing Investigations
We provide consultancy services in investigating deviations in the manufacturing process either remotely or at the client site.
Batch Manufacturing Record Review
We provide consultancy services in reviewing batch manufacturing record reviews for compliance either remotely or at the client site.
Regulatory Compliance
We provide consultancy services for regulatory filings.
cGMP Audit/Inspection
We provide consultancy services in performing internal audits for cGMP compliance.
Inspection Readiness Preparation
We provide consultancy services to prepare your manufacturing and laboratory areas for inspection readiness.
Remediation Activities
We provide consultancy services for remediation projects to rectify manufacturing and laboratory practices that do not comply with the regulations.
SOPs/ Protocols Drafting
We provide consultancy services in drafting the SOPs and Protocols at the client site or remotely.