BCCM - Belgian Coordinated Collections of Microorganisms

We deliver CDMO / CRO services, from 8 sites, working alongside Pharma & Biopharma innovators to advance new therapies to market. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos).
Our drug development services advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include sterile injectables, ophthalmics, capsules, tablets, solutions/suspensions, and topicals.
Our commercialization and manufacturing support comes from our FDA-registered laboratories that provide submission-ready methods validation reports, finished product release testing, ICH Stability programs, raw materials clearance programs, extractable-leachable studies, and full microbiology laboratory support.

Accutest, a global independent and internationally accredited Contract Research Organisation (“CRO”), with more than 20 years of experience and over 700+ employees in supporting the end-to-end services for global bio-pharmaceutical, biotech, medical device, nutraceutical and FMCG companies. Accutest is the market leader among independent CROs, with the highest quality standards and quick turnaround times. We have a strong regulatory track record and numerous accreditation/approvals from global regulatory agencies.

We offer services in 3 verticals:
1. Bio-availability and Bio-equivalence studies (BA/BE) -
2. Clinical Development Services (CDS)- Phase II - IV studies, Post marketing, Investigator initiated & stand alone services (medical writing, regulatory consultancy, clinical data management)
3. Biologics Services - Solutions for biosimilars, novel biologics and non-biological complex generics

Successfully cleared below inspections:
USFDA – 33 times (latest Nov, 2018)
WHO – 23 times (latest Jan, 2019)
DCGI- 20 times (latest Oct, 2016)
EMA – 8 times (latest Dec, 2017)

AXIS Clinicals Limited is one of the most experienced and fastest growing Clinical Research Organization.

Our state-of-the-art facilities houses 500+ dedicated full-time professionals to ensure the quick turn around time with high quality. Our facilities are accredited by DCGI (Drugs Controller General – India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA, France –AFSSAPS / ANSM, GCC, MCC-South Africa etc.

Within short span, we have achieved the milestone of completing 2750+ clinical studies and 1000+ product approvals from various regulatory agencies.

65+ regulatory audits from global competent authorities is testament to our professionalism and dedication to quality studies.

Our Phase II – IV capabilities are growing along with an extended portfolio of Site Management, Medical Writing, and Data Management.

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated contract research, development and manufacturing organization providing scientific services – from early discovery to commercial supply. Our innovative capabilities for novel molecular entities (NMEs) cater to a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods and speciality chemical companies.

Our Discovery services include conducting early-stage research from target identification to delivery of drug candidates for further development. Development services encompass activities from pre-clinical to clinical trials including Drug Substance Development (DSP), Drug Product Development (DPD) and associated services to demonstrate safety, tolerability and efficacy of the selected drug candidate.

Our Manufacturing services for small and large molecules include cGMP-compliant facilities for clinical supplies, registration batches as well as commercial volumes through our API manufacturing plant & disposable Biologics manufacturing facility.

Driving our innovative culture is our highly qualified team of 4200 scientists supported by state-of-the-art infrastructure and market-leading technology. Our scientists have both the skills and the capability to deliver great science, ensure robust data management, IP security & quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.

With 2 Mn sq ft of specialist discovery, development & manufacturing facilities, Syngene offers dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife. We also work with biotech companies pursuing leading-edge science as well as multinationals including GSK and Merck KGaA. Smaller and virtual companies, non-profit institutions, academic centers and start-ups also collaborate with us for their research-related requirements.

Write to us at bdc@syngeneintl.com