 |
 |
| Suggy can you provide some introductory text here to introduce the section before we get to listing the services and their bullet points? It should be probably about 4-8 sentences. |
 |
|
| Dosage Forms & API |
 |
Development of Drug Delivery Systems -
Controlled and Modified Releases, Liposomes,
Aerosols and DPI; Transdermals |
 |
 |
Process Development and Optimization for
APIs |
 |
 |
Formulation of Large and Small Molecules for
Solid, Liquids, Semisolid and Sterile Products |
 |
 |
Package Development including Container
Closure Integrity |
 |
 |
Stability Testing & Expiration Dating Programs
for Product Specification |
 |
 |
Intellectual Property Development and Management |
 |
 |
Device Design and Improvements |
 |
 |
Analytical Method Development and
Validation |
 |
 |
Pharmacokinetics & Pharmacodynamics |
 |
Bioavailability / Bioequivalence (IVIVC) |
 |
 |
SUPAC |
 |
 |
Preclinical and Clinical Programs |
|
| Manufacturing Operations |
 |
Non-Sterile Products Manufacturing |
 |
 |
Manufacturing of APIs |
 |
 |
Trouble Shooting |
 |
 |
Process and Equipment Design and Optimization |
 |
 |
Process Development and Optimization for APIs |
 |
 |
Manufacturing Operations and Controls |
|
| Quality Management Systems & Control Programs |
 |
Document Preparation and Management |
 |
 |
Laboratory Systems and Specifications |
 |
 |
Method Transfer and Validation |
 |
 |
Sampling Plans |
 |
 |
Trend Analysis |
|
| Process Validation & System Qualification |
 |
Validation Procedures and Protocols |
 |
 |
Equipment & System Qualifications |
 |
 |
Change Control Program |
 |
 |
Computer Systems and Computer Controlled
Operations |
|
| Facilities & System Design |
 |
HVAC & Water Systems |
 |
 |
Sterilization and Sanitary Requirements |
 |
 |
Dust Control |
 |
 |
Designing GMP and GLP requirements into
Production, R&D, Laboratory & Pilot Facilities |
|
| Regulatory Affairs (CMC) & Audits |
 |
International Regulatory Dossiers |
 |
 |
Labeling |
 |
 |
Product Recall Requirements |
 |
 |
Performing GMPs, GLPs & GCPs for Audits:
· LVPs & SVPs
· Dosage Forms & API
· Diagnostics & Devices |
 |
 |
Performing Quality and Control Change
based:
· Application Verification
· Pre-Approval Inspection
· Due Diligence |
 |
 |
Preparation of Regulatory Documents |
|
| Business Management |
 |
Company and Product Acquisitions |
 |
 |
Business Development Programs |
 |
 |
Writing of Business Plans |
 |
 |
Outsourcing Assessments |
 |
 |
Due Diligence Audits for M&A |
 |
 |
Benchmarking Studies |
 |
 |
Providing Tools for Reducing Time & Cost |
 |
 |
Productivity Analysis |
 |
 |
Setting Performance Goals |
 |
Program and Project Management Controls |
 |
 |
Intellectual Property Protection |
 |
 |
Strategic Objectives & Alliances |
 |
 |
Implementing Accountability & Performance
Models |
 |
 |
Implementing Customized Excellence Projects
for R&D Excellence, Manufacturing
Excellence, QA Excellence |
|
| Training |
 |
Overview of Regulatory Considerations |
 |
 |
GMP Training in:
· Routine Manufacturing Operations
· Validation
· Documentation Control
· Sterile Product Production:
· Clean Room Techniques
· Personnel Practices
· Sterilization
· Lyophilization
· Quality Control Laboratory |
 |
 |
Technical Training |
 |
 |
Leadership and Supervisory Training |
 |
 |
In-House Trainging |
|
| Product, Process, Program & Project (4P) Management |
 |
Product & Process Assessment |
 |
 |
Technology Transfer from R&D to Marketing |
 |
 |
R&D, Manufacturing and Quality Systems -
Evaluation of Human Resource Requirements
and Capabilities |
|