- CQA, Auditing, Inspection Management
- Data Integrity
- Initiatives, 21 CFR Part 11
- Investigation/Deviation Management
- Material and Supplier Quality
- Project Management
- Quality Assurance and Quality Control
- Quality Engineering & QAV
- Quality Systems
- Remediation initiatives, Gap Analysis, Auditing, Inspection Readiness
Pharmaceutical Consulting Services & Jobs
ALKU is proud to be the 3rd largest life sciences staffing firm in the US (SIA), connecting pharma businesses with top talent in the industry. ALKU’s Pharmaceutical Consultants provide expert staffing and solutions for the pharmaceutical, biotech, and cell and gene therapy industries.
If you’re a Pharmaceutical Consultant looking for opportunities, click here.
Area of Expertise
Our pharmaceutical consulting solutions cover remediation projects, facility expansions, quality assurance, compliance, manufacturing, R&D, and project management. We focus on client satisfaction, offering tailored staffing services to help your business thrive. Whether you need strategic consulting or hands-on project support, ALKU delivers the talent you need to succeed.
Quality and Compliance
Gain confidence in your quality systems with expert consultants who bring years of experience in QA/QC, data integrity, FDA audits, regulatory compliance, and process improvement. Let us help you ensure your pharma and biotech operations meet the highest standards.
Regulatory, Clinical, and Medical Affairs
ALKU helps you navigate the complexities of the regulatory landscape throughout the product lifecycle. Our team can help with all aspects of the regulatory submission process, including regulatory operations and Regulatory CMC support. Additionally, our team has industry experts to support clinical affairs, medical affairs, and HEOR.
Automation
ALKU specializes in providing expert consultants to help pharmaceutical companies execute reliable, efficient, and compliant automation projects. From planning and implementation to upgrades and support, we ensure seamless project delivery. Our services include project management, scheduling, validation, and controls to keep projects on time, within budget, and aligned with business goals.
Engineering & Validation
Accelerate your projects with comprehensive engineering and validation support. Whether it’s facility expansions, retrofitting, or process validation, our pharmaceutical team ensures seamless execution and high-quality results.
Skill sets we place
Our consultants support critical roles across the pharmaceutical industry, including:
Engineering/Project Management
- Capital Projects
- Environmental Health & Safety
- New Facilities, Facility Expansions/Retrofitting/Renovations
- Project Management
- Technology Transfer
Validation
- CQV, C&Q, Authoring & Executing Protocols (IQ, OQ, PQ, DQ), MVP/VMP
- CSV/Data Integrity, Risk Assessments, Data Integrity Remediation Project Plans
- Equipment, Process, Cleaning, Facility/Utility, Packaging, Shipping Validation
- Validation
- Validation Project Management
Manufacturing Sciences & Technology
- Analytical Development, Method Development/Method Validation
- Process Development
- Process Development/Analytical Development, Formulation, Process Sciences
- Process Engineers (Product Transfer or Manufacturing Scale Up)
- Production Engineers, Tech Services, Technical Writing
Regulatory Affairs
- Labeling/Advertising & Promotion
- Project Management
- Publishing
- Regulatory CMC
- Regulatory Operations
- Regulatory Strategy
Clinical Affairs
- Clinical Pharmacology
- Clinical Researchers
- Clinical Scientists
- CRAs
- CTAs
- CTMs/CPMs
Medical Affairs
- HEOR/RWE/RWD
- Medical Communications
- Medical Education
- Medical Information
- Medical Operations
- MSLs/KOLs
DCS
- Emerson DeltaV
Batch DeltaV Programming, System Design, System Integration, and Commissioning - Rockwell Automation (Allen Bradley and PlantPAx)
Programming, System Design, System Integration, and Commissioning - Honeywell
- Siemens
PLC & SCADA
- Allen Bradley
Micro 800, CompactLogix, ControlLogix, FactoryTalk, Honeywell, Siemens, Wonderware/AVEVA, ABB, Ignition
MES, Data Historian & Virtualization
- Syncade, PAS-X, Siemens, AVEVA PI, PharmaSuite
HMI
- Programming, Configuration, Integration with Control Systems, Upgrades
Project Management, Project Scheduling, Project Controls
- CQA, Auditing, Inspection Management
- Data Integrity
- Initiatives, 21 CFR Part 11
- Investigation/Deviation Management
- Material and Supplier Quality
- Project Management
- Quality Assurance and Quality Control
- Quality Engineering & QAV
- Quality Systems
- Remediation initiatives, Gap Analysis, Auditing, Inspection Readiness
Engineering/Project Management
- Capital Projects
- Environmental Health & Safety
- New Facilities, Facility Expansions/Retrofitting/Renovations
- Project Management
- Technology Transfer
Validation
- CQV, C&Q, Authoring & Executing Protocols (IQ, OQ, PQ, DQ), MVP/VMP
- CSV/Data Integrity, Risk Assessments, Data Integrity Remediation Project Plans
- Equipment, Process, Cleaning, Facility/Utility, Packaging, Shipping Validation
- Validation
- Validation Project Management
Manufacturing Sciences & Technology
- Analytical Development, Method Development/Method Validation
- Process Development
- Process Development/Analytical Development, Formulation, Process Sciences
- Process Engineers (Product Transfer or Manufacturing Scale Up)
- Production Engineers, Tech Services, Technical Writing
Regulatory Affairs
- Labeling/Advertising & Promotion
- Project Management
- Publishing
- Regulatory CMC
- Regulatory Operations
- Regulatory Strategy
Clinical Affairs
- Clinical Pharmacology
- Clinical Researchers
- Clinical Scientists
- CRAs
- CTAs
- CTMs/CPMs
Medical Affairs
- HEOR/RWE/RWD
- Medical Communications
- Medical Education
- Medical Information
- Medical Operations
- MSLs/KOLs
DCS
- Emerson DeltaV
Batch DeltaV Programming, System Design, System Integration, and Commissioning - Rockwell Automation (Allen Bradley and PlantPAx)
Programming, System Design, System Integration, and Commissioning - Honeywell
- Siemens
PLC & SCADA
- Allen Bradley
Micro 800, CompactLogix, ControlLogix, FactoryTalk, Honeywell, Siemens, Wonderware/AVEVA, ABB, Ignition
MES, Data Historian & Virtualization
- Syncade, PAS-X, Siemens, AVEVA PI, PharmaSuite
HMI
- Programming, Configuration, Integration with Control Systems, Upgrades
Project Management, Project Scheduling, Project Controls
Why Partner with a Pharmaceutical Consultant?
Discover the advantages of leveraging expert consultants for your pharmaceutical projects, including:
→ Access to niche expertise for specialized challenges.
→ Quick scalability to meet project timelines.
→ Compliance with evolving regulatory standards.
→ Seamless integration of innovative technologies.
→ Cost-effective solutions for complex projects.
Expert Support from Start to Finish
At ALKU, we understand the unique challenges you face in meeting regulatory standards while driving innovation. Our expertise in the pharmaceutical and healthcare industries ensures tailored solutions to overcome regulatory challenges while fostering innovation and development. Find tailored solutions to keep your operation compliant and productive, no matter the complexity.
Simplify Your Hiring Process with ALKU Pharmaceutical Staffing Services
Set your projects up for success by partnering with ALKU. Fill out the form below to connect with our team of Pharmaceutical experts. Once you submit your inquiry, a dedicated Account Manager will reach out to discuss your needs and match you with the perfect consultant.
Our Awards
Frequently Asked Pharmaceutical Consulting Questions
Outsourcing pharmaceutical consulting services offers numerous benefits for pharmaceutical companies, including access to specialized expertise, cost savings, and flexibility. By partnering with external consultants, companies can tap into a wealth of industry knowledge and experience without the need to maintain a full-time in-house team allowing them to focus on core business activities.
Pharmaceutical consulting services can assist in optimizing supply chain processes, from procurement and inventory management to distribution and logistics. By implementing best practices and leveraging technology, consultants provide companies with strategic solutions to streamline operations and enhance overall supply chain performance.
When selecting a pharmaceutical consulting partner, it’s essential to consider several key factors. Look for a firm with a proven track record of success in the pharmaceutical industry and expertise in your specific area of need, whether it’s regulatory compliance, quality assurance, or market access. Additionally, consider the firm’s reputation, client testimonials, and the depth of its resources and capabilities to ensure it can deliver the results you need.