aspecx.
pharmaceutical consultants
EMPOWERING YOUR GROWTH THROUGH
cGMP COMPLIANCE
SERVICE OFFERINGS
Our team of professional knowledgeable experts brings decades of diverse global cGMP experience and best practices to your project. Whether you are just starting up or are trying to comply with standards and regulations or need assistance with product development and regulatory approval, we can put you on an accelerated solid path to success. We have delivered and are still delivering for our multi-national companies round the region.
All our services are undertaken in accordance with the latest FDA, European Medicines Agency and other international agency regulations and guidelines are are founded on a Philosophy of Excellence through our personalized hands-on experience and our trained resources.
Being a regional company, our multinational team of experienced consultants consists of individuals whom are able to converse fluently and deliver written documentations in both the English, Bahasa Malayu and Chinese language. Below are some of our service offerings we offer, feel free to contact us if you have some requirements that are not listed below.
01 / cGMP Consulting Services
We are able to deliver our cGMP Consulting Services to all regulated companies at every stage of growth, developing custom compliant solutions and collaborating with all levels of your business and stake holders. Listed below are some of the service offerings we provide:
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GAP Analysis
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Regulatory Mock Audit/Inspection
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Regulatory ‘One Stop’ cGMP Certification Services
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Regulatory Inspection ‘War Room’ Management
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Regulatory Inspection on-site Translation Services
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483/Observation reply/CAPA definition
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Quality System review/implementation
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Site Information Technology Policies implementation
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cGMP Manufacturing facility design review
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PQR development and preparation
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Deviation Management
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Change Control Management
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Corrective Action Preventive Action (CAPA) Management
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Complaint handling
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Batch Record Review
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Quality deficiency reports
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Release preparation/review
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Review of marketing authorization documents
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Qualified Person mentoring program
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Mentoring program for daily operations
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Equipment Specification generation and procurement
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Regulatory filling for IND, NDA, ANDA
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Site Data Integrity framework definition
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Site IT policies in support of Data Integrity
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Aseptic/Terminal Sterile Manufacturing guidance
02 / Validation Services
For the pharmaceutical industry, commissioning and validation play a very important part in the compliance process. To put it simply, it is about the process of generated documented evidence to proof a process, equipment etc. functions as per initially defined. Without that, the process, equipment etc. cannot be used for operational purposes. Listed below are some of the service offerings we provide:
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Site Validation framework Definition
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Manufacturing Process Validation (PV): Biotech, Vaccines, Pharma, Med Devices, Consumer Products etc.
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Packaging Process Validation
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Cleaning Validation
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Detergents Evaluation
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Sanitizing Agents Studies
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Recovery Studies
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Microbial Load
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Active Drug Solubilities and Sampling
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Surfaces Areas and Sampling Points
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Holding Times (Prior and Post Cleaning Process)
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Worst Case Studies
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Bracketing
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Analytical Methods Transfer/Validation
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Alarm and Action Limit
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Computerized System Validation CSV
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21 CFR Part 11, Annex 11 etc.
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Network / IT Infrastructure Validation
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Risk Based C&Q, Cleaning and Process Validation
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Validation Master Plans Definition
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Process Support / Monitoring
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Maintenance of Validated Status: Verification vs. Validation
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Revalidation
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Validation Review for Vendor Packages
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Validation Remediation / Legacy Systems etc.
ABOUT US
OUR STORY
Aspecx Pharmaceutical Consultants (APC) was established in the early 2000s, at a time when Singapore was rapidly expanding its Life Science/Pharmaceutical industry.
Big brand name pharmaceutical companies were coming to Singapore to set up manufacturing/research facilities, bringing with them opportunities due to Singapore's lack of experienced qualified pharmaceutical consultants/validation specialists. This created the opportunity for APC to be founded along with the overseas returning pioneering batch of consultants in the Singapore Pharmaceutical Industry, and we have been fortunate to actively expand rapidly and participate in numerous greenfield EPCMV, consulting, and validation projects to this day.
OUR VISION
Our mission is to guide pharmaceutical companies through their process of attaining cGMP compliance excellence, providing cost effective and attainable solutions to the challenges and opportunities posed by the increasing need for globalization, emerging technology and competition.
Our role is to act as a trusted advisor, providing objective and results-oriented analysis, solutions and implementation.
Our motto being,
'because your compliance matters'
CHINA MARKET
Aspecx Pharmaceutical Consultants have since 2011 expanded into People's Republic of China with a physical presence in both Beijing and Shanghai through AB+, Abioplus Life Science Management 洛施德GMP咨询 www.abioplus.cn.
Within these short few years, we have since established ourself to be the leading Life Science Pharmaceutical company in China with both local and foreign joint venture pharmaceuticals companies as our clients helping them successfully meet their quality objectives and also gain US FDA, EU EDQM, IMPA etc Good Manufacturing Practice (GMP) certification.
OUR CLIENTELES
and many others ...
GET IN TOUCH
Singapore
22 Sin Ming Lane, #06-76
Midview City, Singapore 573969
People's Republic of China
Shanghai
Room 307-308, Building 5, No.2377 Shenkun Road, Minhang District, Shanghai. 201106