7717 KEELER AVENUE
SKOKIE, IL 60076
ph: 773-663-5312
fax: 847-673-8248
aukeje
ANS And Associate Inc. Consulting Services mission are to provide:
Services critical to Biotech, Pharmaceutical, Chemical and Engineering industries’ in delivering safe and effective products as quickly and efficiently as possible by getting it right first time.
Critical services to organizations and institutions in the areas of Equipment design (URS, ED, FDS), procurement and qualifications (FAT, DQ/IQ/OQ/PQ), Lab Instrumentation, procurement, installation/qualifications and training.
Efficient and cost-effective services at a fraction of the actual cost by proactively working with the manufacturers to resolve any issue(s) that may cause potential delay to the project, milestone deviation, or compliance risk in a timely manner and maximize return on investment.
Training, Scientific, Technical and Regulatory support to clients on a continuing basis to help advance the urgently needed projects and accelerate decision-making process.
In-depth knowledge of entire drug development process, Chemistry, Manufacturing, Controls in EU, US FDA and Canadian regulatory environment including procedures for filing IND (CMC), NDA , ANDA and PAI documentations
Formulation Development including Physico-Chemical Characterizations of raw materials and products, Feasibilty formulations and compability/stabilty studies
-Manufacturing Process Development including process development plan, project plan, Risk assessment, project inplementation, monitoring and control
-Scale Up including process and Equipment Scale Up to pilot, phases I, II, III and commercial batch sizes.
-cGMPManufacturing of Engineering, clinical, stabibilty, Demo, Registration and Commercial prducts
-Inter/external Technology Transfer to manufacturing
- Validations
-Regulatory Compliance
-Environmetal Health and Safety Services in compliance to OSHA and EPA regulatory requirements
-Process Engineering including process equipment design (URS, ED, FDS, DQ), procurement, qualifications (FAT/IQ/OQ/PQ) and operational Training.
-Lab Instrumentation including writing justifications, procurement, qualifications (/IQ/OQ/PQ) and use Traning on for physicochemical characterizations including compliance with 21 CFR part 11 (Electronic Records) where necessary.
ANS And Associate Inc. Professionals have extensive Product Development, TechTransfer to manufacturing, Validations and Product Improvements experience in Oral (Liquid and Solid), Nasal (Liquid and powder), Inhalation (MDI, MDPI and Nebulized Proteins) and Topical (Gels, Creams, Ointments) Dosage Forms and their delivery devices. We also provide services to chemical industries in the areas of product research, formulation and teting as well as chemical process scale up and transfer to manufacturing site.
In Engineering field, we provide Process Engineering services to industries and institutions including equipment design (URS, ED, FDS, DQ), procurement, qualifications (FAT/IQ/OQ/PQ) and operational Training.
-Lab Instrumentation including writing justifications, procurement, qualifications (/IQ/OQ/PQ) and use Traning on for physicochemical characterizations including compliance with 21 CFR part 11 (Electronic Records) where necessary.
7717 KEELER AVENUE
SKOKIE, IL 60076
ph: 773-663-5312
fax: 847-673-8248
aukeje