Services

image14

These are some of our services:

1. API/Intermediate sourcing

a.   FDA-inspected API and API-intermediate manufacturers located in

  • i. Europe
  • ii. China
  • iii. India
  • iv. United States
  • v. Canada
  • vi. Mexico

b. Development R&D Labs located in Europe, China, and India

  • i. Small Molecules

1. Virtually all scalable, commercial chemical manufacturing techniques represented

2. Cytotoxics and other containment technologies available

3. Scalable from milligrams to kilograms

  • ii.  Biological

1. Fermentation

2. Enzymatic

  • iii. Peptides and oligonucleotides
  • iv. Technology can be developed in our labs or we can transfer methodology from our customer’s lab

c. Generic API development

d. NCE development


2. Injectable dose form sourcing

a. Product development capabilities for vial, syringe, bag technologies

b. FDA-inspected and approved manufacturing sites


3. Analytical Support Services

a. Development of critical product and biological assays

  • i.   Virtually all state-of-the-art technologies represented

b.  Development of specifications

c.  Evaluation and comparison

  • i. Chemical entities
  • ii. cGMP FDA-approved facilities

d. Support activities at pre-IND to commercial manufacture

e. Product QA clearance

  • i. Pharmaceutical and chemical products
  • ii. Dose form


4. Consulting services:

a.     Cost analysis:

  • i. evaluate chemical syntheses and provide insight into projected cost to manufacture
  • ii. evaluate cost performance data for specific processes and aid in process improvement discussions

b. Product portfolio analysis to determine probability profile for generic market emergence

c. Product life cycle management

  • i. Analyze available information on specific markets related to a specific customer’s product or product portfolio
  • ii. Develop strategy to handle the evolution of the product from new market entrant to mature generic product

d. Due Diligence

  • i. On-site inspection of potential acquisition targets
  • ii. Virtual evaluation of specific technologies
  • iii. Quality and regulatory review of QA/QC and Regulatory Affairs groups with a focus on risk assessment
  • iv. Manufacturing process evaluation
  • v. Operational financial analysis
  • vi. Product portfolio assessments

e. Private Equity consulting: GFC works with Private Equity houses in evaluating and assessing potential acquisition targets

f. Technical Writing:

  • i. White paper analyses
  • ii. IND support
  • iii. NDA/ANDA support
  • iv. DMF support
  • v. Literature reviews