Product Development

Material Selection, Product Design, Formulation Development,
Design of Experiments (DOE), Bio-Enhancement for Poorly Soluble Compound, Costs of Goods eduction.                                                                                        More >>

Regulatory Affairs: U.S. 21 CFR Regulations, ICH Interpretation, Technical Writing for non clinical sections of IND, CTA, CTX, NDA, ANDA, BLA, CTD, MAA, Clinical Trial Monitoring, New Substance Notifications, Product Safety Communication, Cosmetic Labelling and Label Claims.
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GxP: cGMP, CAPA, Quality Systems, OOS Documentation, Gap Analysis, Inspection Readiness, Annual Product Review and Trending, Change Control, Vendor and Supply Chain Audits.
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Manufacturing: Process Development, Product and Process Validation, Product Scale Up, FMEA, Process Improvement and Cost of Goods Reduction.                                                  More >>
Analytical: Method Development and Validation, Stability Design, Writing Protocols and Amendments, Design Testing Plans, OOS Investigation, Equipment Calibration and Validation, Cleaning Verification, Method Transfer.                                        More >>
Audits:

Remediation of FDA 483s and Warning Letters, Crisis Intervention, Internal GMP Audits, FDA Inspection Readiness, Third Party Compliance Audits.                              More >>

Training: Laboratory Practice, GMP/GLP/GCP, Auditors, Product Development, Method and Technology Transfer.                                                                                   More >>
Technical Writing:

SOPs, Protocols, Reports, Agreements and Contracts, SR&ED.                          More >>