20

years of GMP

experience

What We Do

Project lead from idea to launch

Support your company in any action connected to Global Business Development, Regulatory Affairs and Pharmacovigilance in the pharma, OTC, FSMP, dietary supplements and medical device industries.

Being consultants to the regulated life science industries, we help our clients achieve and maintain full compliance with Health Canada, FDA, EMEA and WHO regulatory requirements.

Facilitate commercialization of your new products and help you interface with various agencies to address regulatory concerns.

Bring technical expertise in quality assurance, project management & facilities commissioning (Equipment and IT structure and components), productivity & efficiency improvement, outsourcing & supply chain management, validation, and regulatory compliance.

Provide strategic and management consulting services,

We use our thorough knowledge, market experience and business contacts to match providers of products with buyers, including:

Surveying possible partners and local competitors, and profound research for a new product.

Support during business negotiations and contract preparation

In-out licensing and business development

Preparing an entry strategy with a business plan, as well as a registration strategy and timeline

We assist our clients in developing strategies for market penetration as well as analyzing the market access.

Our Services

FACILITY DESIGN & PROCESSES

We provide high quality design that meet your needs and reflect your required processes.

QUALITY ASSURANCE / QUALITY CONTROL

We provide quality assurance and quality control services to pharmaceutical, biotechnology and medical device companies assisting them in interfacing with regulators and addressing regulatory questions and problems.

MARKET ACCESS / REGULATORY ADVICE

The firm assists clients performing gap assessments against applicable regulatory requirements, develop mitigation strategies and a corrective action plan, address gaps, and enhance inspection readiness.

FACILITY COMMISSIONING & VALIDATION

Our team includes validation specialists with extensive expertise in commissioning and validation of pharmaceutical and biotechnology facilities.

QUALIFICATION AND VALIDATION OF IT STRUCTURE AND COMPUTERIZED SYSTEMS

MBBioservices offers compliant IT structure and its related software, and tailor-designed computer validation support.

PRODUCTIVITY & EFFICIENCY IMPROVEMENT

Our Consultants are experienced professionals in building and implementing productivity improvement programs.

SUPPLY CHAIN / COLD CHAIN

The firm provides site evaluations and auditing services for clients assisting them in optimizing and qualifying their supply chain.

PACKAGING & LABEL DESIGN

The firm provides packaging and labeling services and assists in creating and delivering specific design for your secondary and tertiary packaging products.

LEGAL SERVICES

We provide legal Pharma services related to patent registration, contractual transfer of technology, partnerhsip and JV.

Where We Work

Our multicultural and multilingual professionals are uniquely positioned to optimize collaborations with your teams, no matter where you are located.

Our consultants enjoy strategic collaborations with quality auditors, consultants and professionals in key regions of the world allowing seamless project transition and team integration across four continents.