- Europe, North America, …
- Vietnam, Venezuela, …
- Human Medicines, Biopharmaceuticals, …
- Service category
- Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, …
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- Audit / compliance service
- Drug safety
- Filling service
- Language service
- Pharmacovigilance services
- Regulatory services
- Writing medical
- Writing scientific
Global Regulatory Affairs
As a long established Regulatory Consultancy and Service Provider, we offer an extensive portfolio of business development and regulatory affairs solutions covering services for prescription (branded/generic, new chemical entities, novel formulations/administrations) OTC and herbal/nutraceutical products.
Whatever your pharma or biotech therapeutic focus, our unique combination of global resources, expert consulting and deep experience ensure you can maximize your product’s commercial potential.
Our global presence includes an extensive network of specialists located in EU and EEC member states, MENA and CIS countries, as well as the US, plus affiliate offices in China and Japan. Our consultants have extensive knowledge and experience in all aspects of regulatory affairs across various industry disciplines and a wide range product profiles. And because we stay abreast of current legislation, regulatory requirements, industry initiatives and regulatory interpretations around the world, you don’t have to.
Our end-to-end service offering spans Bioavailability/Bioequivalence (BA/BE) and Phase I studies, Phase II to Phase IV and PMS studies,medical writing, Biostatistics and Statistical Programming Services, Clinical Data Management (CDM), GCP Audits and training.
The portfolio has been developed specifically to help customers expedite the regulatory submission process and speed time to market.
For Phase I studies, ELC Group is providing its pharmaceutical customers with full regulatory consulting support, protocol design, assistance with ethics committee submissions, plus access to a Clinical Pharmacology unit and bio-analytical testing – delivered from a centre that is approved by all major regulatory agencies. Additional services include clinical study management, method development and validation, data management, PK analysis, statistical analysis and report writing.
For Phase II to Phase IV and PMS studies, ELC Group offers a full range of services, including study feasibility, site and investigator selection, site monitoring, project management, clinical trial supply management, and vendor management.
As part of its Clinical Trials portfolio, ELC Group is also providing expert biostatistics and statistical programming services – covering all major therapeutic areas – and delivering insights into trial design as well as developing complex statistical analysis plans. In addition, ELC Group offers Clinical Data Management services for early clinical development and late phase clinical development programmes, including managing data for pharmacovigilance and Pharmacokinetic/Pharmacodynamic (PK/PD) services.
With our Clinical Affairs portfolio, we are delivering a full-service solution to help ease the regulatory approval process and shorten key timelines for our customers.
Our Clinical Affairs services are fully customisable, and can be offered on a standalone basis or as part of our integrated full-service package, offering ultimate flexibility to our pharmaceutical customers looking to expedite product delivery and create a competitive advantage in the market. The clinical affaris service portfolio is rounded off with ELC Group’s Good Clinical Practice (GCP) auditing, quality assessment and risk analysis services, plus GCP training and workshops for IEC/IRB. All services are complemented by ELC Group’s expert medical writing capability for regulatory submissions, scientific communications and medico-marketing material.
CMC (Chemistry, Manufacturing and Control)
CMC plays an important role in the market success of a drug. CMC professionals help to ensure safe and effective pharmaceutical products are released to the market. We can offer support across all stages of the product lifecycle and have experience with a variety of dose forms. ELC group offers a wide range of services and experienced consultation to customers.
ELC group is has a very knowledgeable CMC technical team with over 25 years of experience. Our experts have a detailed understanding of all areas of CMC including production, quality assurance, formulation & analytical method developments.
We have CMC experience with different pharmaceutical forms such as Solid orals, injectables (sterile solutions, powder for injections, complex injectables, pre-filled syringes & multi dose vials), MDIs, DPIs, combination drugs, oral solutions, diagnostic kits, Ophthalmics, liquid anaesthetics, dermal preparations etc. We also have good experience with biologics and biosimilar applications.
ELC Group's CMC services will allow you to:
- gain greater knowledge of the quality issues affecting your product
- develop increased awareness of regulatory expectations
- recognize issues in regulatory and plant documentation
- understand the successful filing strategy
- identify critical pitfalls in dossier preparations
- receive guidance on changing legislation
- get advice on critical CMC issues on a wide range of dosage forms and molecules
- help you to evaluate the dossier from assessors point of view
Audits and Training
We offer the following audits and training consultancy:
- Good Clinical Practice (GCP) Audits
- Good Vigilance Practice (GVP) Audits
- Good Manufacturing Practice (GMP) Audits
- Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice Audits
- Training on the above plus standard operating procedures (SOP) writing
- GDP Audits [Scope: audit of warehouses and distributors, supply chain robustness, role of the responsible person, review of QMS, testing of recall procedures and protocols]
Language Solutions for Translation and Localization
ELC GROUP provides powerful solutions to mission critical in-territory marketing challenges. We have helped hundreds of leading companies in diverse industries prepare products and content to accelerate their global growth and opportunity.
If your pan-European websites lack consistency in terms of design, content and feel, then we can help. And when it comes to multilingual packaging, labelling and instruction documentation we offer in-depth detailed knowledge that ensures full compliance with local regulatory guidelines.
Our multilingual content services include support for web content, online technical support, eLearning programs and marketing information. What’s more, we’re experts at applying out solutions across your extended supply chain – including suppliers and subcontractors.
We have extensive experience assisting medical device and IVD companies with international and quality assurance issues. With our support you can obtain regulatory clearance, maintain compliance, and increase your sales in the fast growing medical device market.
Whether you’re entering US or EU markets for the first time or simply introducing a new device, we can help with anything from submission preparation, compliance and audits plus post marketing reporting, through to distributor qualification.
(Regulation (EC) No 1907/2006)
Approvals, Certificates, Authorisations
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