API Development consultants

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Michael Gamlen MRPharmS PhD
Pharmaceutical Consultant and Managing Director/founder of PDS

Expert in outsourcing all aspects of product development.

Specialist expertise in particle science and particle size analysis.

Responsible for product development of wide range of new drugs currently on the market.

Michael Gamlen has over 30 years experience of tablet development.

API development
Pharmaceutical outsourcing

Helping you maximise the full commercial potential
of your products or technologies using our operational and regulatory support

Our services include:

• Sourcing and importing materials, including active pharmaceutical ingredients from China and India
• Drop shipment
• Pharmaceutical and chemical process consulting
• Biocatalysis
• Contract chemistry R&D and outsourcing manufacturing
• CMC project management
• Formulation and packaging
• Process hazard assessment
• Environmental protection
• Safe handling of highly potent substances
(primary and secondary manufacturing)
• GMP standards
• Interim management
• Training
• Supplier auditing
• Technical research and editing

Adverse event tracking
Biotech QC specialist
Clinical trials manufacturing
Contract QP
Contractor management
PAI preparation
Electronic publishing
eCTD systems
GXP auditing
Herbal medicines
Inspection preparation
Interim management
Laboratory management
Medical device registration
New product introduction
Outsourcing
Packaging and labelling
Particle science
Pharmaceutical development
Project management
Quality management
Qualified Person services
QP certification
QP release
QP support
Regulatory affairs
Regulatory due diligence
Training and development

Pharmaceutical and Chemical - API Development

from research to the patient