Operational Due Diligence - The Pharmaceutical, Healthcare and Related Industries
Rephine consultants can undertake the necessary audits and inspections for due diligence for mergers and acquisitions.
Areas covered focusing particularly on the operational issues will include:
Facility Design and Services
Management Team and Structure
Products and Processes
Level of operational and GMP compliance; compliance of process, material, and personnel flows with regulatory requirements.
Suitability, strengths, weaknesses, capability, stability, succession planning.
Compliance with specifications and regulatory requirements.
Quality Systems
Health and Safety
Quality Control Laboratories
How quality systems work. Simplicity and attainment of regulatory requirements.
Company policy, track record, record keeping, potential future liabilities.
Level of equipment, staffing, and operation relative to regulatory standards.
Customer Complaints
Relationship with Regulatory Authorities
Plant and Equipment
Nature of system and use for information, training, and improvement.
Nature and extent.
Adequacy, condition, validatability, when validated.
Fabric and Technical Infrastructure
Work in progress
IT systems
Nature, condition, maintenance schedules and plans.
Validation of quantity and timeframes and value.
Nature, extent, validation, replacement plans.
Engineering and Maintenance
Training
Security
Nature of system of Planned Preventative Maintenance and a Calibration Programme, and extent of fulfillment.
Adequacy, frequency, nature of records.
Physical security of plant. Plans and programmes for theft and sabotage prevention.
Other areas that typically are covered in the due diligence process are:-
- Legal
- Financial
- Commercial
- Environmental
- Tax
- Technology
- Employment
Rephine can provide a 'one-stop-shop' for all aspects of due diligence in the M & A process in the Pharmaceutical, Healthcare, or related industries.