Laval, Quebec (PRWEB) May 13, 2013
Biotrial is pleased to announce that following an inspection of Biotrial Bioanalytical Services (BBS) located in Laval, Quebec by the Centre for Drug Evaluation and Research (CDER) division of the FDA, no FDA Form-483 was issued. The inspection was conducted over a five-day period during which the bioanalytical laboratory facilities, procedures, and study specific data were thoroughly reviewed.
BBS President, Michael Mancini, Ph.D., P.Chem., said, We are particularly proud to share the information with our clients that the 2013 routine pre-approval inspection resulted in no observations and that it demonstrated that we have maintained our uncompromising commitment to quality. We have exciting development plans for the future and are ready to deliver outstanding services to our customers.
We are very pleased to have obtained such a positive result, said Jean-Marc Gandon, President and CEO, especially since we know that we are in a globally competitive market; we have set the bar very high and shown that the bioanalytical services we deliver at BBS are exceptional. The fact that the FDA had no observations demonstrates a high level of conformity to the regulations, thereby assuring our customers that the studies performed at BBS are carried out with cutting-edge science, competence and state-of-the-art equipment that is what we deliver.
BBS is a GLP-certified laboratory accredited by the Standards Council of Canada (SCC), Canadas national Good Laboratory Practices monitoring authority. In addition to the FDA inspections, the laboratory has been inspected by AGES (Austrian Agency for Health and Food Safety). BBS provides bioanalytical services to support clinical and non-clinical development, including method development & validation, feasibility studies, technology transfer, bioavailability & bioequivalence studies, as well as therapeutic drug monitoring.
BBS employs a group of highly skilled scientists, has more than 250 validated assays that include some of the most challenging methods, has numerous exclusive proprietary methods, 25,000 sq. ft. of cutting-edge laboratories and workstations, and over 21 mass spectrometers including state-of-the-art ABSciex API 6500.
Founded in 1989, Biotrial is a leading CRO specialized in Early Development with a wide range of services from Non-Clinical Pharmacology, Phase I studies, Phase II-IV Trial Management, Bioanalysis, Oncology, Data Management, Biostatistics, ECG & Imaging Core Lab (QT/QTc Trials, Psychometric Testing, Imaging, EEG/PSG Assessment), Regulatory Affairs to Medical Writing.
Based in France, Belgium, the United Kingdom, Canada and the United States, Biotrial performs hundreds of studies a year and offers tailor-made solutions to Biotech and Pharmaceutical companies.
For further information, please contact Anne Peron on [+33] (0)2 99 599 191 or visit http://www.biotrial.com.
(PRWEB) May 15, 2013
Play On Words LLC, led by highly respected speech language pathologist Sherry Artemenko, announces 2013′s Spring PAL (Play Advances Language) Winners. This recognition is the toy industrys only program directed by a credentialed speech-language expert recognizing the language learning edge in exceptional toys, games and books. Distinguished by unique design, quality and character, these PAL winners can generate rich play that advances language. Sherry’s 35 years of child development experience with over 15,000 hours working with kids empower her PAL selections, popular blog, private practice and media appearances.
“I’m excited to see companies taking a closer look at their products to find the language learning potential for ALL kids to play together, while making it easier for parents by listing their toy’s skills on the packaging or in learning guides in the box. Manufacturers are valuing my advice on how to use their toys to maximize learning, ‘We can’t wait to see what you think!’ The PAL seal, awarded to global enterprises and start-ups alike, differentiates the companies who know the marketplace now demands products that are not only fun, but educational. The PAL Award seal says just that.
Spring 2013 Play Advances Language (PAL) Award Winners listed by language learning category:
EARLY DEVELOPMENT: Sherry’s daily experience in pediatric speech therapy gives her an eye for the best products to build attention, vocabulary, and concepts through play, preparing children for their first sounds, words and sentences. From stacking and squirting pals to pulling a circus train, kids learn essential language skills.
Babipouce Pink Cotton Flower by Corolle
Bobo Buddy by R.E. Baby Products, Inc.
Elf Grenadines Heart by Corolle
My First Play World Farm: Stacking Cubes by HABA
My First Puzzles Garden Animals by Ravensburger
My Nature Pals Stroll by Tiny Love
Racing Round Stacking Pyramid by Janod
Sneaky, Snacky Squirrel Game! by Educational Insights
Softimals Safari Set by Infinitoy, Inc.
Splash n Slide Waterpark Wonder by B kids
Stack n Squirt Pals by B kids
Story Circus Baby Train by Janod
Toddler Build And Play Cubes by Lego
LANGUAGE STRUCTURE: These outstanding products can build language structure, often teaching vocabulary, concepts or grammar while delivering fun. Predicting and drawing conclusions from a science experiment, learning position words while searching for “Sunshine,” or using the language of math to defeat Ninja Turtle enemies, all strengthen communication.
Animal Soup The Mixed-Up Animal Board Game! by The Haywire Group
Bear In Underwear Backpack Adventure Board Game! by The Haywire Group
Being Frank by Donna W. Earnhardt and Andrea Castellani
Clifford Science Series by The Young Scientists Club
Frog Wobble by MindWare
Green by Laura Vaccaro Seeger
Hello Sunshine! by Thinkfun
Magnetibook 4 Seasons by Janod
On The Farm Whos In The Barnyard? by Ravensburger
PicWits! by MindWare
Qualities by SimplyFun
Red Cat Blue Cat by Jenni Desmond
Rhyme Out: The Triple Rhyming Game by Educational Insights
Teenage Mutant Ninja Turtles Clash Alley Strategy Game by Wonder Forge
The Ant and the Grasshopper by Rebecca Emberley and Ed Emberley
Whats It? By Peaceable Kingdom
Wummelbox by Wummelbox
PRE (READING): Searching for a word written in the round, spinning the alphabet with associated pictures or listening to an early reader popping up tall and high, children can pick up essential skills to promote reading.
ABC Puzzle And Book: My First Puzzle Book by Tiger Tales
Alphabet A-Z by Plan Toys
Block Crayon 3-in-1 Activity Table by Wooky Entertainment
Loco Lingo Kindergarten by HABA
Pig Has a Plan by Ethan Long
See n Spin Alphabet Rack by B kids
Up! Tall! And High! by Ethan Long
WordARound by Thinkfun
STORY-TELLING/ PRETEND PLAY: Whether protecting Fort Brave from the outlaws, engaging in realistic puppet play, or taking the ferry boat out for a sail, children enter the world of pretend, creating their own stories with plenty of flexible props to guide their imagination. Oral story-telling precedes writing as kids learn the steps to create a good narrative.
A Home For Bird by Philip C. Stead
Alpaca Puppet by Folkmanis, Inc.
Artzooka! Cupcake Creations by Wooky Entertainment
Artzooka! Recycle Sticker Creations by Wooky Entertainment
Artzooka! Surprise Match Boxes by Wooky Entertainment
Bebe Bath and Accessories By Corolle
Bible Toys Prayer Bear
Easy Turn Coupe by Step2
Fairy Tale Blocks by Plan Toys
Ferry Boat by Green Toys
Fire Engine by Plan Toys
Fixin Fun Outdoor Grill by Step2
Friends Heartlake City Pool by Lego
HABA Puppet Theater
Imagine i CAN Feel Better MD by Manhattan Toy
Imagine i Can Pirate Treasures by Manhattan Toy
Leopard Shark Puppet by Folkmanis, Inc.
Little Hedgehog Puppet by Folkmanis, Inc.
My 1st Career Gear Zookeeper by Aeromax Inc.
My Little Nenuco Travel With Me by Famosa
Parking Garage by Plan Toys
Pinypon Fairies by Famosa
Playmobil 1.2.3 Take Along Barn
Playmobil 1.2.3 Take Along Fire Station
Playmobil Native American Camp With Totem Pole
Playmobil Western Fort
Rocket by Green Toys
Sky Dragon Puppet by Folkmanis, Inc.
SmartMax Flower Palace by Smart Toys and Games, Inc.
Tractor by Green Toys
WOWs Sammy Sea Patrol by Ravensburger
SOCIAL LANGUAGE: Pairing closely with pretend play, social language blossoms when children play with toys that encourage extended social interactions. Working cooperatively to follow the instructions of a magic move wand, or racing mice to capture a huge chunk of cheese before the cat stops them promotes one-on-one interaction.
Magic Moves Electronic Wand by Educational Insights
Lilliputiens’ Ophelie And Her Chicks by HABA
Penguin And Pinecone by Salina Yoon
Puppet on-a-Stick by Educational Insights
SQUIGGLE On-The-Go by Randomline, Inc.
Super Sized Floor Puzzle USA Map by Ravensburger
The Great Cheese Chase by Peaceable Kingdom
Congratulations to our PAL Winners who are listening to their markets and delivering a powerful value proposition, namely, great language learning paired with play.
To see all Playonwords PAL Award winners, go to: