Adnan Sabir

Principal Consultant at PCS

• United States - Alabama
• My current job since March 2009

Pharma Consulting Services, LLC

Pharma Consulting Services (PCS) has been offering technocentric services for: Formulation and Process development; scale-up and tech transfer; manufacturing challenges; compliance to cGMP; and clinical studies on a global scale for 10 years.
Essential Solutions
Strategic areas of service and mentorship include: Drawing simplified, easy to understand roadmaps for establishing QbD/PAT based development and manufacturing processes of pharmaceuticals, of either new or already approved products (Reference: ICH Guidelines 8, 9, 10, and 11)
We provide: formulations development (of Pharmaceuticals and Nutraceuticals) for IR, MR, and other unique and innovative dosage forms; and simplification of batch records, processes and controlled documentation for zero deviation during manufacturing
We handle a Seamless Technology Transfer based on a Model of 10 Commandments which include logistics and technical guidance - Right at First Time
We deliver practical and compliant approaches for “Molecule to Market” and “Life Cycle Management (LCM) for significant timeline and fiscal resource reduction
We research an appropriate API sourcing for you to meet your specific needs based on product profile you would like to develop and manufacture
PCS conveys complete and comprehensive directions for Quality Management System (QMS) and Quality Risk Management (QRM) during entire Life Cycle Management (LCM) of the product

Focused areas of support and quality for cGMP and FDA compliance include: providing scaffolding for 21st Century Quality Initiatives of FDA for QbR, QbD, & PAT (ICH GL 8, 9, 10 and 11); delivering customized stepwise strategies for developing robust manufacturing; SOP creation and review; GMP compliance (deviation, CAPA, Change Control, complaint, and Audit)
We assist in establishing Quality Metrics, writing technical quality agreements, and auditing of API, excipient, and manufacturing facilities in US, India, or RoW to comply with cGMP regulations
Educational Solutions
Pharma Consulting Services provides tailored training for a variety of subjects in several modalities. Some of the topic include:
Technology Transfer: A Seamless Technology Transfer (Model consisting of Strategy, Concurrent Database Collection, and Case Histories)
Development for Solid Dosage Forms: Traditional Tablets and Capsules, chewable Tablets, ODT, Modified Release (MR), Target Drug Delivery System, Physicochemical Characterization of APIs and Excipients, Selection of Excipients (for generics and brands based on regulations), Tablet Film Coating (functional and non-functional)
Optimization of Unit Operations: Excellent knowledge and expertise are available in handling challenges in Blending, Granulating, tableting, and film coating
Fluid Bed Technology: For granulation, drying, and film coating (multiparticulate coating)
Bioavailability: Poorly Soluble and polymorphic drugs
Outsourcing: All about outsourcing decisions and answers to typical and exceptional questions such as What, Why, Where, and How to find and work with CMOs complying with FDA regs
PAT/QbD: Basically, everything from ICH Guide lines Q8 -11, 21st Century GMP Initiatives by FDA), and Quality Risk Management (QRM) as applied to LCM of product being developed