New product R&D for pre-clinical studies

R&D for proof of concept studies

Formulation development and optimization

Market dosage form selection, manufacturing process and packaging configuration

Troubleshoot existing formulation, manufacturing process and packaging configuration

Analytical method development and / or troubleshoot analytical methods for API, intermediate and finished product

Pharmaceutical equivalence

Bioavailability and clinical equivalence

Clinical supplies manufacturing

Clinical supplies packaging

Scale-up

Technical or Site Transfers

Launch product(s) for commerce

Product due diligence

Trouble-shoot existing product

FDA filings for:

Pre-IND (Pre-Investigational New Drug)

IND (Investigational New Drug)

NDA (New Drug Application)

BLA (Biologics License Application)

ANDA (Abbreviated New Drug Application)

FDA comment letters

Site cGMP (Current Good Manufacturing Practices)

Regulatory Compliance

Post-Marketed Product(s)

Audit, assess and prepare a manufacturing, packaging and analytical testing laboratory for FDA inspections

Audit, assess and prepare for pre-approval inspections for NDA (brand), BLA (biologics brand or biosimilar) and ANDA (generic) products

Remediation activities to meet cGMP requirements

Support FDA-483 and / or warning letter response

Consent decree remediation plans

On-site assistance during FDA inspections

Project management for all remediation programs

Failed PAI Inspections

Coordinating recall efforts

Import detention resolution

Audit, assess and prepare for pre-approval inspections for NDA (brand), BLA (biologics brand or biosimilar) and ANDA (generic) products

Inspect facilities, equipment, and laboratories

Review pertinent documents that support GMP and client specifications

Assess quality management systems, SOPs and associated cGMP documents

Review validation of manufacturing equipment, product process, and equipment cleaning

Assess vendor certification programs

Review method validation (analytical and microbiological)

Evaluate data integrity

Computer systems validation (CSV) audits

21 CFR part 11 compliance review

Trial Master File audits

Vendor audits including contract research organizations (CROs), Central Labs, IRBs, and Data Management.

Quality system development

CAPA management

Gap analysis

Readiness assessment

SOP development

Technical writing: SOP’s, validation protocols & reports, annual product reviews, audit responses, and other technical reports

Electronic quality management systems

Process validation

Cleaning validation

Equipment qualification and validation

Laboratory controls

Analytical method validation

Develop training programs

Review and audit of dossier for a product

Purpose: acquisition by a company or file with FDA or get FDA approval by addressing FDA comment letters

Pre-clinical, IND, Phase 1, 2 or 3 clinical studies data and respective chemistry, manufacturing and controls (CMC) report, product development report and ANDA

Analytical & QC data review and audit for FDA submission / exhibit batch

Process validation assessment and remediation to meet US-FDA requirements

Technology transfer to a US-FDA approved manufacturing and testing site 

Scale-up to commercial batch size of a product

Review preliminary construction design documentation/ engineering drawings to assure compliance

Develop preliminary hazard analysis  

Assess and review requirements, specifications, and drawings for water systems, HVAC, sterilization, temperature and humidity controls

Develop laboratory, environmental and processing-room requirements

Qualify facilities for sterile, non-sterile products

Project management of materials, equipment and personnel

Perform equipment IQ/ OQ/ PQ

Develop facility validation and qualification protocols and execution

Conduct regular audits during pre, present and post construction and installation phases

Scientific and technical expert advisory for intellectual property / patent of a product during a patent litigation